Drill guide fixtures, cranial insertion fixtures, and related methods and robotic systems

ABSTRACT

A drill guide fixture may be configured to prepare a skull for attachment of a cranial insertion fixture. The drill guide fixture may include a central drill guide and a bone anchor guide at a base of the drill guide fixture. The central drill guide may define a central drill guide hole therethrough, wherein the central drill guide hole has a first opening at a base of the drill guide fixture and a second opening spaced apart from the base of the drill guide fixture. The bone anchor drill guide may define a bone anchor drill guide hole therethrough, and the bone anchor drill guide hole may be offset from the central drill guide hole in a direction that is perpendicular with respect to a direction of the central drill guide hole. Related cranial insertion fixtures, robotic systems, and methods are also discussed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of U.S. applicationSer. No. 16/209,266, filed Dec. 4, 2018, which is incorporated in itsentirety herein for all purposes.

FIELD

The present disclosure relates to medical devices, and moreparticularly, medical devices for cranial procedures related methods androbotic systems.

BACKGROUND

For image-guided insertion of a needle or electrode into the brain, thesurgeon may first secure a metal frame to the patient's skull usingthree or more pins. This frame is then automatically registered to thebrain anatomy by taking a CT scan of the skull and frame andautomatically detecting locations of fiducials on the frame within thescan, thereby allowing transformation between the coordinate system ofthe scan and the coordinate system of the frame. After the surgeon plansthe desired trajectories into the brain on the CT images (typically withenhanced visualization from co-registered MR images), a multiaxialmechanical arc mechanism that has been calibrated to the frame'scoordinate system is adjusted to hold a guide tube at the appropriateposition relative to the skull and aligned with the planned trajectory.The surgeon then inserts the needle through this guide tube. Since theguide tube is interconnected to the skull via the mechanical arc and theframe, there may be a reduced chance during insertion of the needle thatthe patient might move relative to the guide tube, even if the patientis bumped, breathes, coughs, etc.

A possible robot-guided alternative may be to register a tracking camerato a robot and to an array on the patient's skull, then for the robot toautomatically position a guide tube held by its end-effector next to theskull in line with the desired trajectory. The surgeon would then inserta needle through the robot-held guide tube. In such a method, however,sudden movement of the patient could lead to relative movement of theneedle and the brain. For example, if the patient were to voluntarily orinvoluntarily contract muscles or cough, a rapid jerking movement of thepatient could occur. Since the robot is rigidly mounted to the floor,the robot's guide tube may remain stationary relative to the patient,and if the needle was within the guide tube and the brainsimultaneously, the needle could slice brain tissue laterally. If duringneedle insertion, the robot is actively and continuously adjusting itsposition through optical or force feedback, it may be possible for therobot to quickly reposition the guide tube so that it remains stationaryrelative to the brain even during such movement, but currently availablefeedback/response times may be insufficient to track such rapidmovements, and the feedback path (e.g., line of sight for opticaltracking) may need to remain unimpaired throughout the procedure.

SUMMARY

According to some embodiments of inventive concepts, a surgical robotsystem for attaching an electrode holder to a skull of a patient isdescribed, the electrode holder configured to receive an electrode to beinserted into a brain of the patient. The surgical robot system includesa robot base comprising a computer, a robot arm coupled to the robotbase, an end effector configured to be coupled to the robot arm, a guidetube having a detachable electrode holder disposed at a distal tip ofthe guide tip and a tracking array disposed near a proximal end of theguide tube, the guide tube configured to couple to the end effector, anda tripod mechanism configured to slide over the guide tube and allowfine adjustment of an angle of the guide tube relative to the skull.

According to some embodiments of inventive concepts, a method of using asurgical robot for attaching an electrode holder to a skull of a patientis described, the electrode holder configured to receive an electrode tobe inserted into a brain of the patient. The method includes planning atrajectory, attaching an electrode holder to the skull using thesurgical robot, and using the electrode holder for insertion of theelectrode into the brain. The surgical robot includes a robot basecomprising a computer, a robot arm coupled to the robot base, and an endeffector configured to be coupled to the robot arm. The guide tubeincludes a detachable electrode holder disposed at a distal tip of theguide tip and a tracking array disposed near a proximal end of the guidetube, the guide tube configured to couple to the end effector, and atripod mechanism configured to slide over the guide tube and allowadjustment of an angle of the guide tube relative to the skull. Themethod further includes positioning a dynamic reference base on theskull, positioning a temporary skirt fixture to the dynamic referencebase, obtaining medical images of the dynamic reference base andtemporary skirt feature, registering the dynamic reference base to themedical images using the temporary skirt fixture, removing the temporaryskirt fixture, planning a trajectory of the electrode using the obtainedmedical images, using the robot to move the robot arm and end-effectorto a desired location adjacent to the skull along the plannedtrajectory, using a drill to provide a hole in the skull while the robotguides the drill, providing the guide tube and electrode holder in thehole and removing the robot, lowering and locking the tripod mechanismto the guide tube, providing the tracking array to the guide tube andchecking alignment of the guide relative to the planned trajectory,inserting an electrode into the guide tube and through the electrodeholder; and removing the guide tube from the electrode holder.

DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the disclosure and are incorporated in a constitute apart of this application, illustrate certain non-limiting embodiments ofinventive concepts. In the drawings:

FIG. 1 is an overhead view of a potential arrangement for locations ofthe robotic system, patient, surgeon, and other medical personnel duringa surgical procedure;

FIG. 2 illustrates the robotic system including positioning of thesurgical robot and the camera relative to the patient according to oneembodiment;

FIG. 3 illustrates a surgical robotic system in accordance with anexemplary embodiment;

FIG. 4 illustrates a portion of a surgical robot in accordance with anexemplary embodiment;

FIG. 5 illustrates a block diagram of a surgical robot in accordancewith an exemplary embodiment;

FIG. 6 illustrates a surgical robot in accordance with an exemplaryembodiment;

FIGS. 7A-7C illustrate an end-effector in accordance with an exemplaryembodiment;

FIG. 8 illustrates a surgical instrument and the end-effector, beforeand after, inserting the surgical instrument into the guide tube of theend-effector according to one embodiment;

FIGS. 9A-9C illustrate portions of an end-effector and robot arm inaccordance with an exemplary embodiment;

FIG. 10 illustrates a dynamic reference array, an imaging array, andother components in accordance with an exemplary embodiment;

FIG. 11 illustrates a method of registration in accordance with anexemplary embodiment;

FIG. 12A-12B illustrate embodiments of imaging devices according toexemplary embodiments;

FIG. 13A illustrates a portion of a robot including the robot arm and anend-effector in accordance with an exemplary embodiment;

FIG. 13B is a close-up view of the end-effector, with a plurality oftracking markers rigidly affixed thereon, shown in FIG. 13A;

FIG. 13C is a tool or instrument with a plurality of tracking markersrigidly affixed thereon according to one embodiment;

FIG. 14A is an alternative version of an end-effector with moveabletracking markers in a first configuration;

FIG. 14B is the end-effector shown in FIG. 14A with the moveabletracking markers in a second configuration;

FIG. 14C shows the template of tracking markers in the firstconfiguration from FIG. 14A;

FIG. 14D shows the template of tracking markers in the secondconfiguration from FIG. 14B;

FIG. 15A shows an alternative version of the end-effector having only asingle tracking marker affixed thereto;

FIG. 15B shows the end-effector of FIG. 15A with an instrument disposedthrough the guide tube;

FIG. 15C shows the end-effector of FIG. 15A with the instrument in twodifferent positions, and the resulting logic to determine if theinstrument is positioned within the guide tube or outside of the guidetube;

FIG. 15D shows the end-effector of FIG. 15A with the instrument in theguide tube at two different frames and its relative distance to thesingle tracking marker on the guide tube;

FIG. 15E shows the end-effector of FIG. 15A relative to a coordinatesystem;

FIG. 16 is a block diagram of a method for navigating and moving theend-effector of the robot to a desired target trajectory;

FIGS. 17A-17B depict an instrument for inserting an expandable implanthaving fixed and moveable tracking markers in contracted and expandedpositions, respectively;

FIGS. 18A-18B depict an instrument for inserting an articulating implanthaving fixed and moveable tracking markers in insertion and angledpositions, respectively;

FIG. 19A depicts an embodiment of a robot with interchangeable oralternative end-effectors;

FIG. 19B depicts an embodiment of a robot with an instrument styleend-effector coupled thereto;

FIG. 20 is a block diagram illustrating a robotic controller accordingto some embodiments of inventive concepts;

FIG. 21 is a diagram illustrating a temporary cranial insertion fixtureaccording to some embodiments of inventive concepts;

FIG. 22 is a diagram illustrating a drill guide fixture according tosome embodiments of inventive concepts;

FIG. 23 is a cross sectional view illustrating an electrode retentionimplant according to some embodiments of inventive concepts;

FIG. 24 is a cross sectional view illustrating an electrode guidancetube according to some embodiments of inventive concepts;

FIG. 25 is a cross sectional view illustrating an electrode retentionimplant and electrode wires in a skull according to some embodiments ofinventive concepts;

FIG. 26 is a cross sectional view illustrating guide tube supportmechanism according to some embodiments of inventive concepts;

FIG. 27 illustrates a coordinate system for a robotic system accordingto some embodiments of inventive concepts;

FIGS. 28A, 28B, 28C, and 28D illustrate a head frame and a referencefixture according to some embodiments of inventive concepts;

FIGS. 29A, 29B, 29C, and 29D illustrate a head frame used with separatereference fixtures according to some embodiments of inventive concepts;

FIGS. 30A and 30B illustrate use of localizing features with a roboticend effector according to some embodiments of inventive concepts;

FIG. 31 illustrates use of patterned targets with a robot including amonocular camera according to some embodiments of inventive concepts;

FIGS. 32A-32B illustrate different views of a dynamic reference arrayconsistent with the principles of the present disclosure;

FIGS. 33A-33B illustrate a dynamic reference array without a temporaryskirt fixture and with a temporary skirt fixture, respectively,consistent with the principles of the present disclosure;

FIG. 34A illustrates a guide tube and detachable electrode holderconsistent with the principles of the present disclosure;

FIG. 35B illustrates a guide tube, detachable electrode holder, and atripod mechanism consistent with the principles of the presentdisclosure;

FIG. 35C illustrates a guide tube, detachable electrode holder, tripodmechanism, and a tracking array consistent with the principles of thepresent disclosure;

FIG. 35 illustrates a dynamic reference array and an end effectorconsistent with the principles of the present disclosure;

FIG. 36 illustrates a dynamic reference array and an end effectorconsistent with the principles of the present disclosure;

FIG. 37 illustrates a dynamic reference array and a guide tube with adetachable electrode holder consistent with the principles of thepresent disclosure;

FIG. 38 illustrates a dynamic reference array, a guide tube with adetachable electrode holder, and tripod mechanism consistent with theprinciples of the present disclosure;

FIG. 39A illustrates a view of aligning a guide tube with a trajectoryconsistent with the principles of the present disclosure; and

FIG. 39B illustrates a dynamic reference array, a guide tube with adetachable electrode holder and a tracking array, and tripod mechanismconsistent with the principles of the present disclosure.

DETAILED DESCRIPTION

It is to be understood that the present disclosure is not limited in itsapplication to the details of construction and the arrangement ofcomponents set forth in the description herein or illustrated in thedrawings. The teachings of the present disclosure may be used andpracticed in other embodiments and practiced or carried out in variousways. Also, it is to be understood that the phraseology and terminologyused herein is for the purpose of description and should not be regardedas limiting. The use of “including,” “comprising,” or “having” andvariations thereof herein is meant to encompass the items listedthereafter and equivalents thereof as well as additional items. Unlessspecified or limited otherwise, the terms “mounted,” “connected,”“supported,” and “coupled” and variations thereof are used broadly andencompass both direct and indirect mountings, connections, supports, andcouplings. Further, “connected” and “coupled” are not restricted tophysical or mechanical connections or couplings.

The following discussion is presented to enable a person skilled in theart to make and use embodiments of the present disclosure. Variousmodifications to the illustrated embodiments will be readily apparent tothose skilled in the art, and the principles herein can be applied toother embodiments and applications without departing from embodiments ofthe present disclosure. Thus, the embodiments are not intended to belimited to embodiments shown, but are to be accorded the widest scopeconsistent with the principles and features disclosed herein. Thefollowing detailed description is to be read with reference to thefigures, in which like elements in different figures have like referencenumerals. The figures, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope of theembodiments. Skilled artisans will recognize the examples providedherein have many useful alternatives and fall within the scope of theembodiments.

Turning now to the drawing, FIGS. 1 and 2 illustrate a surgical robotsystem 100 in accordance with an exemplary embodiment. Surgical robotsystem 100 may include, for example, a surgical robot 102, one or morerobot arms 104, a base 106, a display 110, an end-effector 112, forexample, including a guide tube 114, and one or more tracking markers118. The surgical robot system 100 may include a patient tracking device116 also including one or more tracking markers 118, which is adapted tobe secured directly to the patient 210 (e.g., to a bone of the patient210). The surgical robot system 100 may also use a camera 200, forexample, positioned on a camera stand 202. The camera stand 202 can haveany suitable configuration to move, orient, and support the camera 200in a desired position. The camera 200 may include any suitable camera orcameras, such as one or more infrared cameras (e.g., bifocal orstereophotogrammetric cameras), able to identify, for example, activeand passive tracking markers 118 (shown as part of patient trackingdevice 116 in FIG. 2 and shown by enlarged view in FIGS. 13A-13B) in agiven measurement volume viewable from the perspective of the camera200. The camera 200 may scan the given measurement volume and detect thelight that comes from the markers 118 in order to identify and determinethe position of the markers 118 in three-dimensions. For example, activemarkers 118 may include infrared-emitting markers that are activated byan electrical signal (e.g., infrared light emitting diodes (LEDs)),and/or passive markers 118 may include retro-reflective markers thatreflect infrared light (e.g., they reflect incoming IR radiation intothe direction of the incoming light), for example, emitted byilluminators on the camera 200 or other suitable device.

FIGS. 1 and 2 illustrate a potential configuration for the placement ofthe surgical robot system 100 in an operating room environment. Forexample, the robot 102 may be positioned near or next to patient 210.Although depicted near the head of the patient 210, it will beappreciated that the robot 102 can be positioned at any suitablelocation near the patient 210 depending on the area of the patient 210undergoing the operation. The camera 200 may be separated from the robotsystem 100 and positioned at the foot of patient 210. This locationallows the camera 200 to have a direct visual line of sight to thesurgical field 208. Again, it is contemplated that the camera 200 may belocated at any suitable position having line of sight to the surgicalfield 208. In the configuration shown, the surgeon 120 may be positionedacross from the robot 102, but is still able to manipulate theend-effector 112 and the display 110. A surgical assistant 126 may bepositioned across from the surgeon 120 again with access to both theend-effector 112 and the display 110. If desired, the locations of thesurgeon 120 and the assistant 126 may be reversed. The traditional areasfor the anesthesiologist 122 and the nurse or scrub tech 124 may remainunimpeded by the locations of the robot 102 and camera 200.

With respect to the other components of the robot 102, the display 110can be attached to the surgical robot 102 and in other exemplaryembodiments, display 110 can be detached from surgical robot 102, eitherwithin a surgical room with the surgical robot 102, or in a remotelocation. End-effector 112 may be coupled to the robot arm 104 andcontrolled by at least one motor. In exemplary embodiments, end-effector112 can comprise a guide tube 114, which is able to receive and orient asurgical instrument 608 (described further herein) used to performsurgery on the patient 210. As used herein, the term “end-effector” isused interchangeably with the terms “end-effectuator” and “effectuatorelement.” Although generally shown with a guide tube 114, it will beappreciated that the end-effector 112 may be replaced with any suitableinstrumentation suitable for use in surgery. In some embodiments,end-effector 112 can comprise any known structure for effecting themovement of the surgical instrument 608 in a desired manner.

The surgical robot 102 is able to control the translation andorientation of the end-effector 112. The robot 102 is able to moveend-effector 112 along x-, y-, and z-axes, for example. The end-effector112 can be configured for selective rotation about one or more of thex-, y-, and z-axis, and a Z Frame axis (such that one or more of theEuler Angles (e.g., roll, pitch, and/or yaw) associated withend-effector 112 can be selectively controlled). In some exemplaryembodiments, selective control of the translation and orientation ofend-effector 112 can permit performance of medical procedures withsignificantly improved accuracy compared to conventional robots thatuse, for example, a six degree of freedom robot arm comprising onlyrotational axes. For example, the surgical robot system 100 may be usedto operate on patient 210, and robot arm 104 can be positioned above thebody of patient 210, with end-effector 112 selectively angled relativeto the z-axis toward the body of patient 210.

In some exemplary embodiments, the position of the surgical instrument608 can be dynamically updated so that surgical robot 102 can be awareof the location of the surgical instrument 608 at all times during theprocedure. Consequently, in some exemplary embodiments, surgical robot102 can move the surgical instrument 608 to the desired position quicklywithout any further assistance from a physician (unless the physician sodesires). In some further embodiments, surgical robot 102 can beconfigured to correct the path of the surgical instrument 608 if thesurgical instrument 608 strays from the selected, preplanned trajectory.In some exemplary embodiments, surgical robot 102 can be configured topermit stoppage, modification, and/or manual control of the movement ofend-effector 112 and/or the surgical instrument 608. Thus, in use, inexemplary embodiments, a physician or other user can operate the system100, and has the option to stop, modify, or manually control theautonomous movement of end-effector 112 and/or the surgical instrument608. Further details of surgical robot system 100 including the controland movement of a surgical instrument 608 by surgical robot 102 can befound in co-pending U.S. patent application Ser. No. 13/924,505, whichis incorporated herein by reference in its entirety.

The robotic surgical system 100 can comprise one or more trackingmarkers 118 configured to track the movement of robot arm 104,end-effector 112, patient 210, and/or the surgical instrument 608 inthree dimensions. In exemplary embodiments, a plurality of trackingmarkers 118 can be mounted (or otherwise secured) thereon to an outersurface of the robot 102, such as, for example and without limitation,on base 106 of robot 102, on robot arm 104, and/or on the end-effector112. In exemplary embodiments, at least one tracking marker 118 of theplurality of tracking markers 118 can be mounted or otherwise secured tothe end-effector 112. One or more tracking markers 118 can further bemounted (or otherwise secured) to the patient 210. In exemplaryembodiments, the plurality of tracking markers 118 can be positioned onthe patient 210 spaced apart from the surgical field 208 to reduce thelikelihood of being obscured by the surgeon, surgical tools, or otherparts of the robot 102. Further, one or more tracking markers 118 can befurther mounted (or otherwise secured) to the surgical tools 608 (e.g.,a screw driver, dilator, implant inserter, or the like). Thus, thetracking markers 118 enable each of the marked objects (e.g., theend-effector 112, the patient 210, and the surgical tools 608) to betracked by the robot 102. In exemplary embodiments, system 100 can usetracking information collected from each of the marked objects tocalculate the orientation and location, for example, of the end-effector112, the surgical instrument 608 (e.g., positioned in the tube 114 ofthe end-effector 112), and the relative position of the patient 210.

The markers 118 may include radiopaque or optical markers. The markers118 may be suitably shaped include spherical, spheroid, cylindrical,cube, cuboid, or the like. In exemplary embodiments, one or more ofmarkers 118 may be optical markers. In some embodiments, the positioningof one or more tracking markers 118 on end-effector 112 can maximize theaccuracy of the positional measurements by serving to check or verifythe position of end-effector 112. Further details of surgical robotsystem 100 including the control, movement and tracking of surgicalrobot 102 and of a surgical instrument 608 can be found in U.S. patentpublication No. 2016/0242849, which is incorporated herein by referencein its entirety.

Exemplary embodiments include one or more markers 118 coupled to thesurgical instrument 608. In exemplary embodiments, these markers 118,for example, coupled to the patient 210 and surgical instruments 608, aswell as markers 118 coupled to the end-effector 112 of the robot 102 cancomprise conventional infrared light-emitting diodes (LEDs) or anOptotrak® diode capable of being tracked using a commercially availableinfrared optical tracking system such as Optotrak®. Optotrak® is aregistered trademark of Northern Digital Inc., Waterloo, Ontario,Canada. In other embodiments, markers 118 can comprise conventionalreflective spheres capable of being tracked using a commerciallyavailable optical tracking system such as Polaris Spectra. PolarisSpectra is also a registered trademark of Northern Digital, Inc. In anexemplary embodiment, the markers 118 coupled to the end-effector 112are active markers which comprise infrared light-emitting diodes whichmay be turned on and off, and the markers 118 coupled to the patient 210and the surgical instruments 608 comprise passive reflective spheres.

In exemplary embodiments, light emitted from and/or reflected by markers118 can be detected by camera 200 and can be used to monitor thelocation and movement of the marked objects. In alternative embodiments,markers 118 can comprise a radio-frequency and/or electromagneticreflector or transceiver and the camera 200 can include or be replacedby a radio-frequency and/or electromagnetic transceiver.

Similar to surgical robot system 100, FIG. 3 illustrates a surgicalrobot system 300 and camera stand 302, in a docked configuration,consistent with an exemplary embodiment of the present disclosure.Surgical robot system 300 may comprise a robot 301 including a display304, upper arm 306, lower arm 308, end-effector 310, vertical column312, casters 314, cabinet 316, tablet drawer 318, connector panel 320,control panel 322, and ring of information 324. Camera stand 302 maycomprise camera 326. These components are described in greater withrespect to FIG. 5. FIG. 3 illustrates the surgical robot system 300 in adocked configuration where the camera stand 302 is nested with the robot301, for example, when not in use. It will be appreciated by thoseskilled in the art that the camera 326 and robot 301 may be separatedfrom one another and positioned at any appropriate location during thesurgical procedure, for example, as shown in FIGS. 1 and 2.

FIG. 4 illustrates a base 400 consistent with an exemplary embodiment ofthe present disclosure. Base 400 may be a portion of surgical robotsystem 300 and comprise cabinet 316. Cabinet 316 may house certaincomponents of surgical robot system 300 including but not limited to abattery 402, a power distribution module 404, a platform interface boardmodule 406, a computer 408, a handle 412, and a tablet drawer 414. Theconnections and relationship between these components is described ingreater detail with respect to FIG. 5.

FIG. 5 illustrates a block diagram of certain components of an exemplaryembodiment of surgical robot system 300. Surgical robot system 300 maycomprise platform subsystem 502, computer subsystem 504, motion controlsubsystem 506, and tracking subsystem 532. Platform subsystem 502 mayfurther comprise battery 402, power distribution module 404, platforminterface board module 406, and tablet charging station 534. Computersubsystem 504 may further comprise computer 408, display 304, andspeaker 536. Motion control subsystem 506 may further comprise drivercircuit 508, motors 510, 512, 514, 516, 518, stabilizers 520, 522, 524,526, end-effector 310, and controller 538. Tracking subsystem 532 mayfurther comprise position sensor 540 and camera converter 542. System300 may also comprise a foot pedal 544 and tablet 546.

Input power is supplied to system 300 via a power source 548 which maybe provided to power distribution module 404. Power distribution module404 receives input power and is configured to generate different powersupply voltages that are provided to other modules, components, andsubsystems of system 300. Power distribution module 404 may beconfigured to provide different voltage supplies to platform interfacemodule 406, which may be provided to other components such as computer408, display 304, speaker 536, driver 508 to, for example, power motors512, 514, 516, 518 and end-effector 310, motor 510, ring 324, cameraconverter 542, and other components for system 300 for example, fans forcooling the electrical components within cabinet 316.

Power distribution module 404 may also provide power to other componentssuch as tablet charging station 534 that may be located within tabletdrawer 318. Tablet charging station 534 may be in wireless or wiredcommunication with tablet 546 for charging table 546. Tablet 546 may beused by a surgeon consistent with the present disclosure and describedherein.

Power distribution module 404 may also be connected to battery 402,which serves as temporary power source in the event that powerdistribution module 404 does not receive power from input power 548. Atother times, power distribution module 404 may serve to charge battery402 if necessary.

Other components of platform subsystem 502 may also include connectorpanel 320, control panel 322, and ring 324. Connector panel 320 mayserve to connect different devices and components to system 300 and/orassociated components and modules. Connector panel 320 may contain oneor more ports that receive lines or connections from differentcomponents. For example, connector panel 320 may have a ground terminalport that may ground system 300 to other equipment, a port to connectfoot pedal 544 to system 300, a port to connect to tracking subsystem532, which may comprise position sensor 540, camera converter 542, andcameras 326 associated with camera stand 302. Connector panel 320 mayalso include other ports to allow USB, Ethernet, HDMI communications toother components, such as computer 408.

Control panel 322 may provide various buttons or indicators that controloperation of system 300 and/or provide information regarding system 300.For example, control panel 322 may include buttons to power on or offsystem 300, lift or lower vertical column 312, and lift or lowerstabilizers 520-526 that may be designed to engage casters 314 to locksystem 300 from physically moving. Other buttons may stop system 300 inthe event of an emergency, which may remove all motor power and applymechanical brakes to stop all motion from occurring. Control panel 322may also have indicators notifying the user of certain system conditionssuch as a line power indicator or status of charge for battery 402.

Ring 324 may be a visual indicator to notify the user of system 300 ofdifferent modes that system 300 is operating under and certain warningsto the user.

Computer subsystem 504 includes computer 408, display 304, and speaker536. Computer 504 includes an operating system and software to operatesystem 300. Computer 504 may receive and process information from othercomponents (for example, tracking subsystem 532, platform subsystem 502,and/or motion control subsystem 506) in order to display information tothe user. Further, computer subsystem 504 may also include speaker 536to provide audio to the user.

Tracking subsystem 532 may include position sensor 504 and converter542. Tracking subsystem 532 may correspond to camera stand 302 includingcamera 326 as described with respect to FIG. 3. Position sensor 504 maybe camera 326. Tracking subsystem may track the location of certainmarkers that are located on the different components of system 300and/or instruments used by a user during a surgical procedure. Thistracking may be conducted in a manner consistent with the presentdisclosure including the use of infrared technology that tracks thelocation of active or passive elements, such as LEDs or reflectivemarkers, respectively. The location, orientation, and position ofstructures having these types of markers may be provided to computer 408which may be shown to a user on display 304. For example, a surgicalinstrument 608 having these types of markers and tracked in this manner(which may be referred to as a navigational space) may be shown to auser in relation to a three dimensional image of a patient's anatomicalstructure.

Motion control subsystem 506 may be configured to physically movevertical column 312, upper arm 306, lower arm 308, or rotateend-effector 310. The physical movement may be conducted through the useof one or more motors 510-518. For example, motor 510 may be configuredto vertically lift or lower vertical column 312. Motor 512 may beconfigured to laterally move upper arm 308 around a point of engagementwith vertical column 312 as shown in FIG. 3. Motor 514 may be configuredto laterally move lower arm 308 around a point of engagement with upperarm 308 as shown in FIG. 3. Motors 516 and 518 may be configured to moveend-effector 310 in a manner such that one may control the roll and onemay control the tilt, thereby providing multiple angles thatend-effector 310 may be moved. These movements may be achieved bycontroller 538 which may control these movements through load cellsdisposed on end-effector 310 and activated by a user engaging these loadcells to move system 300 in a desired manner.

Moreover, system 300 may provide for automatic movement of verticalcolumn 312, upper arm 306, and lower arm 308 through a user indicatingon display 304 (which may be a touchscreen input device) the location ofa surgical instrument or component on a three dimensional image of thepatient's anatomy on display 304. The user may initiate this automaticmovement by stepping on foot pedal 544 or some other input means.

FIG. 6 illustrates a surgical robot system 600 consistent with anexemplary embodiment. Surgical robot system 600 may compriseend-effector 602, robot arm 604, guide tube 606, instrument 608, androbot base 610. Instrument tool 608 may be attached to a tracking array612 including one or more tracking markers (such as markers 118) andhave an associated trajectory 614. Trajectory 614 may represent a pathof movement that instrument tool 608 is configured to travel once it ispositioned through or secured in guide tube 606, for example, a path ofinsertion of instrument tool 608 into a patient. In an exemplaryoperation, robot base 610 may be configured to be in electroniccommunication with robot arm 604 and end-effector 602 so that surgicalrobot system 600 may assist a user (for example, a surgeon) in operatingon the patient 210. Surgical robot system 600 may be consistent withpreviously described surgical robot system 100 and 300.

A tracking array 612 may be mounted on instrument 608 to monitor thelocation and orientation of instrument tool 608. The tracking array 612may be attached to an instrument 608 and may comprise tracking markers804. As best seen in FIG. 8, tracking markers 804 may be, for example,light emitting diodes and/or other types of reflective markers (e.g.,markers 118 as described elsewhere herein). The tracking devices may beone or more line of sight devices associated with the surgical robotsystem. As an example, the tracking devices may be one or more cameras200, 326 associated with the surgical robot system 100, 300 and may alsotrack tracking array 612 for a defined domain or relative orientationsof the instrument 608 in relation to the robot arm 604, the robot base610, end-effector 602, and/or the patient 210. The tracking devices maybe consistent with those structures described in connection with camerastand 302 and tracking subsystem 532.

FIGS. 7A, 7B, and 7C illustrate a top view, front view, and side view,respectively, of end-effector 602 consistent with an exemplaryembodiment. End-effector 602 may comprise one or more tracking markers702. Tracking markers 702 may be light emitting diodes or other types ofactive and passive markers, such as tracking markers 118 that have beenpreviously described. In an exemplary embodiment, the tracking markers702 are active infrared-emitting markers that are activated by anelectrical signal (e.g., infrared light emitting diodes (LEDs)). Thus,tracking markers 702 may be activated such that the infrared markers 702are visible to the camera 200, 326 or may be deactivated such that theinfrared markers 702 are not visible to the camera 200, 326. Thus, whenthe markers 702 are active, the end-effector 602 may be controlled bythe system 100, 300, 600, and when the markers 702 are deactivated, theend-effector 602 may be locked in position and unable to be moved by thesystem 100, 300, 600. Markers 702 may be disposed on or withinend-effector 602 in a manner such that the markers 702 are visible byone or more cameras 200, 326 or other tracking devices associated withthe surgical robot system 100, 300, 600. The camera 200, 326 or othertracking devices may track end-effector 602 as it moves to differentpositions and viewing angles by following the movement of trackingmarkers 702. The location of markers 702 and/or end-effector 602 may beshown on a display 110, 304 associated with the surgical robot system100, 300, 600, for example, display 110 as shown in FIG. 2 and/ordisplay 304 shown in FIG. 3. This display 110, 304 may allow a user toensure that end-effector 602 is in a desirable position in relation torobot arm 604, robot base 610, the patient 210, and/or the user.

For example, as shown in FIG. 7A, markers 702 may be placed around thesurface of end-effector 602 so that a tracking device placed away fromthe surgical field 208 and facing toward the robot 102, 301 and thecamera 200, 326 is able to view at least 3 of the markers 702 through arange of common orientations of the end-effector 602 relative to thetracking device. For example, distribution of markers 702 in this wayallows end-effector 602 to be monitored by the tracking devices whenend-effector 602 is translated and rotated in the surgical field 208.

In addition, in exemplary embodiments, end-effector 602 may be equippedwith infrared (IR) receivers that can detect when an external camera200, 326 is getting ready to read markers 702. Upon this detection,end-effector 602 may then illuminate markers 702. The detection by theIR receivers that the external camera 200, 326 is ready to read markers702 may signal the need to synchronize a duty cycle of markers 702,which may be light emitting diodes, to an external camera 200, 326. Thismay also allow for lower power consumption by the robotic system as awhole, whereby markers 702 would only be illuminated at the appropriatetime instead of being illuminated continuously. Further, in exemplaryembodiments, markers 702 may be powered off to prevent interference withother navigation tools, such as different types of surgical instruments608.

FIG. 8 depicts one type of surgical instrument 608 including a trackingarray 612 and tracking markers 804. Tracking markers 804 may be of anytype described herein including but not limited to light emitting diodesor reflective spheres. Markers 804 are monitored by tracking devicesassociated with the surgical robot system 100, 300, 600 and may be oneor more of the line of sight cameras 200, 326. The cameras 200, 326 maytrack the location of instrument 608 based on the position andorientation of tracking array 612 and markers 804. A user, such as asurgeon 120, may orient instrument 608 in a manner so that trackingarray 612 and markers 804 are sufficiently recognized by the trackingdevice or camera 200, 326 to display instrument 608 and markers 804 on,for example, display 110 of the exemplary surgical robot system.

The manner in which a surgeon 120 may place instrument 608 into guidetube 606 of the end-effector 602 and adjust the instrument 608 isevident in FIG. 8. The hollow tube or guide tube 114, 606 of theend-effector 112, 310, 602 is sized and configured to receive at least aportion of the surgical instrument 608. The guide tube 114, 606 isconfigured to be oriented by the robot arm 104 such that insertion andtrajectory for the surgical instrument 608 is able to reach a desiredanatomical target within or upon the body of the patient 210. Thesurgical instrument 608 may include at least a portion of a generallycylindrical instrument. Although a screw driver is exemplified as thesurgical tool 608, it will be appreciated that any suitable surgicaltool 608 may be positioned by the end-effector 602. By way of example,the surgical instrument 608 may include one or more of a guide wire,cannula, a retractor, a drill, a reamer, a screw driver, an insertiontool, a removal tool, or the like. Although the hollow tube 114, 606 isgenerally shown as having a cylindrical configuration, it will beappreciated by those of skill in the art that the guide tube 114, 606may have any suitable shape, size and configuration desired toaccommodate the surgical instrument 608 and access the surgical site.

FIGS. 9A-9C illustrate end-effector 602 and a portion of robot arm 604consistent with an exemplary embodiment. End-effector 602 may furthercomprise body 1202 and clamp 1204. Clamp 1204 may comprise handle 1206,balls 1208, spring 1210, and lip 1212. Robot arm 604 may furthercomprise depressions 1214, mounting plate 1216, lip 1218, and magnets1220.

End-effector 602 may mechanically interface and/or engage with thesurgical robot system and robot arm 604 through one or more couplings.For example, end-effector 602 may engage with robot arm 604 through alocating coupling and/or a reinforcing coupling. Through thesecouplings, end-effector 602 may fasten with robot arm 604 outside aflexible and sterile barrier. In an exemplary embodiment, the locatingcoupling may be a magnetically kinematic mount and the reinforcingcoupling may be a five bar over center clamping linkage.

With respect to the locating coupling, robot arm 604 may comprisemounting plate 1216, which may be non-magnetic material, one or moredepressions 1214, lip 1218, and magnets 1220. Magnet 1220 is mountedbelow each of depressions 1214. Portions of clamp 1204 may comprisemagnetic material and be attracted by one or more magnets 1220. Throughthe magnetic attraction of clamp 1204 and robot arm 604, balls 1208become seated into respective depressions 1214. For example, balls 1208as shown in FIG. 9B would be seated in depressions 1214 as shown in FIG.9A. This seating may be considered a magnetically-assisted kinematiccoupling. Magnets 1220 may be configured to be strong enough to supportthe entire weight of end-effector 602 regardless of the orientation ofend-effector 602. The locating coupling may be any style of kinematicmount that uniquely restrains six degrees of freedom.

With respect to the reinforcing coupling, portions of clamp 1204 may beconfigured to be a fixed ground link and as such clamp 1204 may serve asa five bar linkage. Closing clamp handle 1206 may fasten end-effector602 to robot arm 604 as lip 1212 and lip 1218 engage clamp 1204 in amanner to secure end-effector 602 and robot arm 604. When clamp handle1206 is closed, spring 1210 may be stretched or stressed while clamp1204 is in a locked position. The locked position may be a position thatprovides for linkage past center. Because of a closed position that ispast center, the linkage will not open absent a force applied to clamphandle 1206 to release clamp 1204. Thus, in a locked positionend-effector 602 may be robustly secured to robot arm 604.

Spring 1210 may be a curved beam in tension. Spring 1210 may becomprised of a material that exhibits high stiffness and high yieldstrain such as virgin PEEK (poly-ether-ether-ketone). The linkagebetween end-effector 602 and robot arm 604 may provide for a sterilebarrier between end-effector 602 and robot arm 604 without impedingfastening of the two couplings.

The reinforcing coupling may be a linkage with multiple spring members.The reinforcing coupling may latch with a cam or friction basedmechanism. The reinforcing coupling may also be a sufficiently powerfulelectromagnet that will support fastening end-effector 102 to robot arm604. The reinforcing coupling may be a multi-piece collar completelyseparate from either end-effector 602 and/or robot arm 604 that slipsover an interface between end-effector 602 and robot arm 604 andtightens with a screw mechanism, an over center linkage, or a cammechanism.

Referring to FIGS. 10 and 11, prior to or during a surgical procedure,certain registration procedures may be conducted to track objects and atarget anatomical structure of the patient 210 both in a navigationspace and an image space. To conduct such registration, a registrationsystem 1400 may be used as illustrated in FIG. 10.

To track the position of the patient 210, a patient tracking device 116may include a patient fixation instrument 1402 to be secured to a rigidanatomical structure of the patient 210 and a dynamic reference base(DRB) 1404 may be securely attached to the patient fixation instrument1402. For example, patient fixation instrument 1402 may be inserted intoopening 1406 of dynamic reference base 1404. Dynamic reference base 1404may contain markers 1408 that are visible to tracking devices, such astracking subsystem 532. These markers 1408 may be optical markers orreflective spheres, such as tracking markers 118, as previouslydiscussed herein.

Patient fixation instrument 1402 is attached to a rigid anatomy of thepatient 210 and may remain attached throughout the surgical procedure.In an exemplary embodiment, patient fixation instrument 1402 is attachedto a rigid area of the patient 210, for example, a bone that is locatedaway from the targeted anatomical structure subject to the surgicalprocedure. In order to track the targeted anatomical structure, dynamicreference base 1404 is associated with the targeted anatomical structurethrough the use of a registration fixture that is temporarily placed onor near the targeted anatomical structure in order to register thedynamic reference base 1404 with the location of the targeted anatomicalstructure.

A registration fixture 1410 is attached to patient fixation instrument1402 through the use of a pivot arm 1412. Pivot arm 1412 is attached topatient fixation instrument 1402 by inserting patient fixationinstrument 1402 through an opening 1414 of registration fixture 1410.Pivot arm 1412 is attached to registration fixture 1410 by, for example,inserting a knob 1416 through an opening 1418 of pivot arm 1412.

Using pivot arm 1412, registration fixture 1410 may be placed over thetargeted anatomical structure and its location may be determined in animage space and navigation space using tracking markers 1420 and/orfiducials 1422 on registration fixture 1410. Registration fixture 1410may contain a collection of markers 1420 that are visible in anavigational space (for example, markers 1420 may be detectable bytracking subsystem 532). Tracking markers 1420 may be optical markersvisible in infrared light as previously described herein. Registrationfixture 1410 may also contain a collection of fiducials 1422, forexample, such as bearing balls, that are visible in an imaging space(for example, a three dimension CT image). As described in greaterdetail with respect to FIG. 11, using registration fixture 1410, thetargeted anatomical structure may be associated with dynamic referencebase 1404 thereby allowing depictions of objects in the navigationalspace to be overlaid on images of the anatomical structure. Dynamicreference base 1404, located at a position away from the targetedanatomical structure, may become a reference point thereby allowingremoval of registration fixture 1410 and/or pivot arm 1412 from thesurgical area.

FIG. 11 provides an exemplary method 1500 for registration consistentwith the present disclosure. Method 1500 begins at step 1502 wherein agraphical representation (or image(s)) of the targeted anatomicalstructure may be imported into system 100, 300 600, for example computer408. The graphical representation may be three dimensional CT or afluoroscope scan of the targeted anatomical structure of the patient 210which includes registration fixture 1410 and a detectable imagingpattern of fiducials 1420.

At step 1504, an imaging pattern of fiducials 1420 is detected andregistered in the imaging space and stored in computer 408. Optionally,at this time at step 1506, a graphical representation of theregistration fixture 1410 may be overlaid on the images of the targetedanatomical structure.

At step 1508, a navigational pattern of registration fixture 1410 isdetected and registered by recognizing markers 1420. Markers 1420 may beoptical markers that are recognized in the navigation space throughinfrared light by tracking subsystem 532 via position sensor 540. Thus,the location, orientation, and other information of the targetedanatomical structure is registered in the navigation space. Therefore,registration fixture 1410 may be recognized in both the image spacethrough the use of fiducials 1422 and the navigation space through theuse of markers 1420. At step 1510, the registration of registrationfixture 1410 in the image space is transferred to the navigation space.This transferal is done, for example, by using the relative position ofthe imaging pattern of fiducials 1422 compared to the position of thenavigation pattern of markers 1420.

At step 1512, registration of the navigation space of registrationfixture 1410 (having been registered with the image space) is furthertransferred to the navigation space of dynamic registration array 1404attached to patient fixture instrument 1402. Thus, registration fixture1410 may be removed and dynamic reference base 1404 may be used to trackthe targeted anatomical structure in both the navigation and image spacebecause the navigation space is associated with the image space.

At steps 1514 and 1516, the navigation space may be overlaid on theimage space and objects with markers visible in the navigation space(for example, surgical instruments 608 with optical markers 804). Theobjects may be tracked through graphical representations of the surgicalinstrument 608 on the images of the targeted anatomical structure.

FIGS. 12A-12B illustrate imaging devices 1304 that may be used inconjunction with robot systems 100, 300, 600 to acquire pre-operative,intra-operative, post-operative, and/or real-time image data of patient210. Any appropriate subject matter may be imaged for any appropriateprocedure using the imaging system 1304. The imaging system 1304 may beany imaging device such as imaging device 1306 and/or a C-arm 1308device. It may be desirable to take x-rays of patient 210 from a numberof different positions, without the need for frequent manualrepositioning of patient 210 which may be required in an x-ray system.As illustrated in FIG. 12A, the imaging system 1304 may be in the formof a C-arm 1308 that includes an elongated C-shaped member terminatingin opposing distal ends 1312 of the “C” shape. C-shaped member 1130 mayfurther comprise an x-ray source 1314 and an image receptor 1316. Thespace within C-arm 1308 of the arm may provide room for the physician toattend to the patient substantially free of interference from x-raysupport structure 1318. As illustrated in FIG. 12B, the imaging systemmay include imaging device 1306 having a gantry housing 1324 attached toa support structure imaging device support structure 1328, such as awheeled mobile cart 1330 with wheels 1332, which may enclose an imagecapturing portion, not illustrated. The image capturing portion mayinclude an x-ray source and/or emission portion and an x-ray receivingand/or image receiving portion, which may be disposed about one hundredand eighty degrees from each other and mounted on a rotor (notillustrated) relative to a track of the image capturing portion. Theimage capturing portion may be operable to rotate three hundred andsixty degrees during image acquisition. The image capturing portion mayrotate around a central point and/or axis, allowing image data ofpatient 210 to be acquired from multiple directions or in multipleplanes. Although certain imaging systems 1304 are exemplified herein, itwill be appreciated that any suitable imaging system may be selected byone of ordinary skill in the art.

Turning now to FIGS. 13A-13C, the surgical robot system 100, 300, 600relies on accurate positioning of the end-effector 112, 602, surgicalinstruments 608, and/or the patient 210 (e.g., patient tracking device116) relative to the desired surgical area. In the embodiments shown inFIGS. 13A-13C, the tracking markers 118, 804 are rigidly attached to aportion of the instrument 608 and/or end-effector 112.

FIG. 13A depicts part of the surgical robot system 100 with the robot102 including base 106, robot arm 104, and end-effector 112. The otherelements, not illustrated, such as the display, cameras, etc. may alsobe present as described herein. FIG. 13B depicts a close-up view of theend-effector 112 with guide tube 114 and a plurality of tracking markers118 rigidly affixed to the end-effector 112. In this embodiment, theplurality of tracking markers 118 are attached to the guide tube 112.FIG. 13C depicts an instrument 608 (in this case, a probe 608A) with aplurality of tracking markers 804 rigidly affixed to the instrument 608.As described elsewhere herein, the instrument 608 could include anysuitable surgical instrument, such as, but not limited to, guide wire,cannula, a retractor, a drill, a reamer, a screw driver, an insertiontool, a removal tool, or the like.

When tracking an instrument 608, end-effector 112, or other object to betracked in 3D, an array of tracking markers 118, 804 may be rigidlyattached to a portion of the tool 608 or end-effector 112. Preferably,the tracking markers 118, 804 are attached such that the markers 118,804 are out of the way (e.g., not impeding the surgical operation,visibility, etc.). The markers 118, 804 may be affixed to the instrument608, end-effector 112, or other object to be tracked, for example, withan array 612. Usually three or four markers 118, 804 are used with anarray 612. The array 612 may include a linear section, a cross piece,and may be asymmetric such that the markers 118, 804 are at differentrelative positions and locations with respect to one another. Forexample, as shown in FIG. 13C, a probe 608A with a 4-marker trackingarray 612 is shown, and FIG. 13B depicts the end-effector 112 with adifferent 4-marker tracking array 612.

In FIG. 13C, the tracking array 612 functions as the handle 620 of theprobe 608A. Thus, the four markers 804 are attached to the handle 620 ofthe probe 608A, which is out of the way of the shaft 622 and tip 624.Stereophotogrammetric tracking of these four markers 804 allows theinstrument 608 to be tracked as a rigid body and for the tracking system100, 300, 600 to precisely determine the position of the tip 624 and theorientation of the shaft 622 while the probe 608A is moved around infront of tracking cameras 200, 326.

To enable automatic tracking of one or more tools 608, end-effector 112,or other object to be tracked in 3D (e.g., multiple rigid bodies), themarkers 118, 804 on each tool 608, end-effector 112, or the like, arearranged asymmetrically with a known inter-marker spacing. The reasonfor asymmetric alignment is so that it is unambiguous which marker 118,804 corresponds to a particular location on the rigid body and whethermarkers 118, 804 are being viewed from the front or back, i.e.,mirrored. For example, if the markers 118, 804 were arranged in a squareon the tool 608 or end-effector 112, it would be unclear to the system100, 300, 600 which marker 118, 804 corresponded to which corner of thesquare. For example, for the probe 608A, it would be unclear whichmarker 804 was closest to the shaft 622. Thus, it would be unknown whichway the shaft 622 was extending from the array 612. Accordingly, eacharray 612 and thus each tool 608, end-effector 112, or other object tobe tracked should have a unique marker pattern to allow it to bedistinguished from other tools 608 or other objects being tracked.Asymmetry and unique marker patterns allow the system 100, 300, 600 todetect individual markers 118, 804 then to check the marker spacingagainst a stored template to determine which tool 608, end effector 112,or object they represent. Detected markers 118, 804 can then be sortedautomatically and assigned to each tracked object in the correct order.Without this information, rigid body calculations could not then beperformed to extract key geometric information, for example, such astool tip 624 and alignment of the shaft 622, unless the user manuallyspecified which detected marker 118, 804 corresponded to which positionon each rigid body. These concepts are commonly known to those skilledin the methods of 3D optical tracking.

Turning now to FIGS. 14A-14D, an alternative version of an end-effector912 with moveable tracking markers 918A-918D is shown. In FIG. 14A, anarray with moveable tracking markers 918A-918D are shown in a firstconfiguration, and in FIG. 14B the moveable tracking markers 918A-918Dare shown in a second configuration, which is angled relative to thefirst configuration. FIG. 14C shows the template of the tracking markers918A-918D, for example, as seen by the cameras 200, 326 in the firstconfiguration of FIG. 14A; and FIG. 14D shows the template of trackingmarkers 918A-918D, for example, as seen by the cameras 200, 326 in thesecond configuration of FIG. 14B.

In this embodiment, 4-marker array tracking is contemplated wherein themarkers 918A-918D are not all in fixed position relative to the rigidbody and instead, one or more of the array markers 918A-918D can beadjusted, for example, during testing, to give updated information aboutthe rigid body that is being tracked without disrupting the process forautomatic detection and sorting of the tracked markers 918A-918D.

When tracking any tool, such as a guide tube 914 connected to the endeffector 912 of a robot system 100, 300, 600, the tracking array'sprimary purpose is to update the position of the end effector 912 in thecamera coordinate system. When using the rigid system, for example, asshown in FIG. 13B, the array 612 of reflective markers 118 rigidlyextend from the guide tube 114. Because the tracking markers 118 arerigidly connected, knowledge of the marker locations in the cameracoordinate system also provides exact location of the centerline, tip,and tail of the guide tube 114 in the camera coordinate system.Typically, information about the position of the end effector 112 fromsuch an array 612 and information about the location of a targettrajectory from another tracked source are used to calculate therequired moves that must be input for each axis of the robot 102 thatwill move the guide tube 114 into alignment with the trajectory and movethe tip to a particular location along the trajectory vector.

Sometimes, the desired trajectory is in an awkward or unreachablelocation, but if the guide tube 114 could be swiveled, it could bereached. For example, a very steep trajectory pointing away from thebase 106 of the robot 102 might be reachable if the guide tube 114 couldbe swiveled upward beyond the limit of the pitch (wrist up-down angle)axis, but might not be reachable if the guide tube 114 is attachedparallel to the plate connecting it to the end of the wrist. To reachsuch a trajectory, the base 106 of the robot 102 might be moved or adifferent end effector 112 with a different guide tube attachment mightbe exchanged with the working end effector. Both of these solutions maybe time consuming and cumbersome.

As best seen in FIGS. 14A and 14B, if the array 908 is configured suchthat one or more of the markers 918A-918D are not in a fixed positionand instead, one or more of the markers 918A-918D can be adjusted,swiveled, pivoted, or moved, the robot 102 can provide updatedinformation about the object being tracked without disrupting thedetection and tracking process. For example, one of the markers918A-918D may be fixed in position and the other markers 918A-918D maybe moveable; two of the markers 918A-918D may be fixed in position andthe other markers 918A-918D may be moveable; three of the markers918A-918D may be fixed in position and the other marker 918A-918D may bemoveable; or all of the markers 918A-918D may be moveable.

In the embodiment shown in FIGS. 14A and 14B, markers 918A, 918 B arerigidly connected directly to a base 906 of the end-effector 912, andmarkers 918C, 918D are rigidly connected to the tube 914. Similar toarray 612, array 908 may be provided to attach the markers 918A-918D tothe end-effector 912, instrument 608, or other object to be tracked. Inthis case, however, the array 908 is comprised of a plurality ofseparate components. For example, markers 918A, 918B may be connected tothe base 906 with a first array 908A, and markers 918C, 918D may beconnected to the guide tube 914 with a second array 908B. Marker 918Amay be affixed to a first end of the first array 908A and marker 918Bmay be separated a linear distance and affixed to a second end of thefirst array 908A. While first array 908 is substantially linear, secondarray 908B has a bent or V-shaped configuration, with respective rootends, connected to the guide tube 914, and diverging therefrom to distalends in a V-shape with marker 918C at one distal end and marker 918D atthe other distal end. Although specific configurations are exemplifiedherein, it will be appreciated that other asymmetric designs includingdifferent numbers and types of arrays 908A, 908B and differentarrangements, numbers, and types of markers 918A-918D are contemplated.

The guide tube 914 may be moveable, swivelable, or pivotable relative tothe base 906, for example, across a hinge 920 or other connector to thebase 906. Thus, markers 918C, 918D are moveable such that when the guidetube 914 pivots, swivels, or moves, markers 918C, 918D also pivot,swivel, or move. As best seen in FIG. 14A, guide tube 914 has alongitudinal axis 916 which is aligned in a substantially normal orvertical orientation such that markers 918A-918D have a firstconfiguration. Turning now to FIG. 14B, the guide tube 914 is pivoted,swiveled, or moved such that the longitudinal axis 916 is now angledrelative to the vertical orientation such that markers 918A-918D have asecond configuration, different from the first configuration.

In contrast to the embodiment described for FIGS. 14A-14D, if a swivelexisted between the guide tube 914 and the arm 104 (e.g., the wristattachment) with all four markers 918A-918D remaining attached rigidlyto the guide tube 914 and this swivel was adjusted by the user, therobotic system 100, 300, 600 would not be able to automatically detectthat the guide tube 914 orientation had changed. The robotic system 100,300, 600 would track the positions of the marker array 908 and wouldcalculate incorrect robot axis moves assuming the guide tube 914 wasattached to the wrist (the robot arm 104) in the previous orientation.By keeping one or more markers 918A-918D (e.g., two markers 918C, 918D)rigidly on the tube 914 and one or more markers 918A-918D (e.g., twomarkers 918A, 918B) across the swivel, automatic detection of the newposition becomes possible and correct robot moves are calculated basedon the detection of a new tool or end-effector 112, 912 on the end ofthe robot arm 104.

One or more of the markers 918A-918D are configured to be moved,pivoted, swiveled, or the like according to any suitable means. Forexample, the markers 918A-918D may be moved by a hinge 920, such as aclamp, spring, lever, slide, toggle, or the like, or any other suitablemechanism for moving the markers 918A-918D individually or incombination, moving the arrays 908A, 908B individually or incombination, moving any portion of the end-effector 912 relative toanother portion, or moving any portion of the tool 608 relative toanother portion.

As shown in FIGS. 14A and 14B, the array 908 and guide tube 914 maybecome reconfigurable by simply loosening the clamp or hinge 920, movingpart of the array 908A, 908B relative to the other part 908A, 908B, andretightening the hinge 920 such that the guide tube 914 is oriented in adifferent position. For example, two markers 918C, 918D may be rigidlyinterconnected with the tube 914 and two markers 918A, 918B may berigidly interconnected across the hinge 920 to the base 906 of theend-effector 912 that attaches to the robot arm 104. The hinge 920 maybe in the form of a clamp, such as a wing nut or the like, which can beloosened and retightened to allow the user to quickly switch between thefirst configuration (FIG. 14A) and the second configuration (FIG. 14B).

The cameras 200, 326 detect the markers 918A-918D, for example, in oneof the templates identified in FIGS. 14C and 14D. If the array 908 is inthe first configuration (FIG. 14A) and tracking cameras 200, 326 detectthe markers 918A-918D, then the tracked markers match Array Template 1as shown in FIG. 14C. If the array 908 is the second configuration (FIG.14B) and tracking cameras 200, 326 detect the same markers 918A-918D,then the tracked markers match Array Template 2 as shown in FIG. 14D.Array Template 1 and Array Template 2 are recognized by the system 100,300, 600 as two distinct tools, each with its own uniquely definedspatial relationship between guide tube 914, markers 918A-918D, androbot attachment. The user could therefore adjust the position of theend-effector 912 between the first and second configurations withoutnotifying the system 100, 300, 600 of the change and the system 100,300, 600 would appropriately adjust the movements of the robot 102 tostay on trajectory.

In this embodiment, there are two assembly positions in which the markerarray matches unique templates that allow the system 100, 300, 600 torecognize the assembly as two different tools or two different endeffectors. In any position of the swivel between or outside of these twopositions (namely, Array Template 1 and Array Template 2 shown in FIGS.14C and 14D, respectively), the markers 918A-918D would not match anytemplate and the system 100, 300, 600 would not detect any array presentdespite individual markers 918A-918D being detected by cameras 200, 326,with the result being the same as if the markers 918A-918D weretemporarily blocked from view of the cameras 200, 326. It will beappreciated that other array templates may exist for otherconfigurations, for example, identifying different instruments 608 orother end-effectors 112, 912, etc.

In the embodiment described, two discrete assembly positions are shownin FIGS. 14A and 14B. It will be appreciated, however, that there couldbe multiple discrete positions on a swivel joint, linear joint,combination of swivel and linear joints, pegboard, or other assemblywhere unique marker templates may be created by adjusting the positionof one or more markers 918A-918D of the array relative to the others,with each discrete position matching a particular template and defininga unique tool 608 or end-effector 112, 912 with different knownattributes. In addition, although exemplified for end effector 912, itwill be appreciated that moveable and fixed markers 918A-918D may beused with any suitable instrument 608 or other object to be tracked.

When using an external 3D tracking system 100, 300, 600 to track a fullrigid body array of three or more markers attached to a robot's endeffector 112 (for example, as depicted in FIGS. 13A and 13B), it ispossible to directly track or to calculate the 3D position of everysection of the robot 102 in the coordinate system of the cameras 200,326. The geometric orientations of joints relative to the tracker areknown by design, and the linear or angular positions of joints are knownfrom encoders for each motor of the robot 102, fully defining the 3Dpositions of all of the moving parts from the end effector 112 to thebase 116. Similarly, if a tracker were mounted on the base 106 of therobot 102 (not shown), it is likewise possible to track or calculate the3D position of every section of the robot 102 from base 106 to endeffector 112 based on known joint geometry and joint positions from eachmotor's encoder.

In some situations, it may be desirable to track the positions of allsegments of the robot 102 from fewer than three markers 118 rigidlyattached to the end effector 112. Specifically, if a tool 608 isintroduced into the guide tube 114, it may be desirable to track fullrigid body motion of the robot 902 with only one additional marker 118being tracked.

Turning now to FIGS. 15A-15E, an alternative version of an end-effector1012 having only a single tracking marker 1018 is shown. End-effector1012 may be similar to the other end-effectors described herein, and mayinclude a guide tube 1014 extending along a longitudinal axis 1016. Asingle tracking marker 1018, similar to the other tracking markersdescribed herein, may be rigidly affixed to the guide tube 1014. Thissingle marker 1018 can serve the purpose of adding missing degrees offreedom to allow full rigid body tracking and/or can serve the purposeof acting as a surveillance marker to ensure that assumptions aboutrobot and camera positioning are valid.

The single tracking marker 1018 may be attached to the robotic endeffector 1012 as a rigid extension to the end effector 1012 thatprotrudes in any convenient direction and does not obstruct thesurgeon's view. The tracking marker 1018 may be affixed to the guidetube 1014 or any other suitable location of on the end-effector 1012.When affixed to the guide tube 1014, the tracking marker 1018 may bepositioned at a location between first and second ends of the guide tube1014. For example, in FIG. 15A, the single tracking marker 1018 is shownas a reflective sphere mounted on the end of a narrow shaft 1017 thatextends forward from the guide tube 1014 and is positionedlongitudinally above a mid-point of the guide tube 1014 and below theentry of the guide tube 1014. This position allows the marker 1018 to begenerally visible by cameras 200, 326 but also would not obstruct visionof the surgeon 120 or collide with other tools or objects in thevicinity of surgery. In addition, the guide tube 1014 with the marker1018 in this position is designed for the marker array on any tool 608introduced into the guide tube 1014 to be visible at the same time asthe single marker 1018 on the guide tube 1014 is visible.

As shown in FIG. 15B, when a snugly fitting tool or instrument 608 isplaced within the guide tube 1014, the instrument 608 becomesmechanically constrained in 4 of 6 degrees of freedom. That is, theinstrument 608 cannot be rotated in any direction except about thelongitudinal axis 1016 of the guide tube 1014 and the instrument 608cannot be translated in any direction except along the longitudinal axis1016 of the guide tube 1014. In other words, the instrument 608 can onlybe translated along and rotated about the centerline of the guide tube1014. If two more parameters are known, such as (1) an angle of rotationabout the longitudinal axis 1016 of the guide tube 1014; and (2) aposition along the guide tube 1014, then the position of the endeffector 1012 in the camera coordinate system becomes fully defined.

Referring now to FIG. 15C, the system 100, 300, 600 should be able toknow when a tool 608 is actually positioned inside of the guide tube1014 and is not instead outside of the guide tube 1014 and justsomewhere in view of the cameras 200, 326. The tool 608 has alongitudinal axis or centerline 616 and an array 612 with a plurality oftracked markers 804. The rigid body calculations may be used todetermine where the centerline 616 of the tool 608 is located in thecamera coordinate system based on the tracked position of the array 612on the tool 608.

The fixed normal (perpendicular) distance DF from the single marker 1018to the centerline or longitudinal axis 1016 of the guide tube 1014 isfixed and is known geometrically, and the position of the single marker1018 can be tracked. Therefore, when a detected distance DD from toolcenterline 616 to single marker 1018 matches the known fixed distance DFfrom the guide tube centerline 1016 to the single marker 1018, it can bedetermined that the tool 608 is either within the guide tube 1014(centerlines 616, 1016 of tool 608 and guide tube 1014 coincident) orhappens to be at some point in the locus of possible positions wherethis distance DD matches the fixed distance DF. For example, in FIG.15C, the normal detected distance DD from tool centerline 616 to thesingle marker 1018 matches the fixed distance DF from guide tubecenterline 1016 to the single marker 1018 in both frames of data(tracked marker coordinates) represented by the transparent tool 608 intwo positions, and thus, additional considerations may be needed todetermine when the tool 608 is located in the guide tube 1014.

Turning now to FIG. 15D, programmed logic can be used to look for framesof tracking data in which the detected distance DD from tool centerline616 to single marker 1018 remains fixed at the correct length despitethe tool 608 moving in space by more than some minimum distance relativeto the single sphere 1018 to satisfy the condition that the tool 608 ismoving within the guide tube 1014. For example, a first frame F1 may bedetected with the tool 608 in a first position and a second frame F2 maybe detected with the tool 608 in a second position (namely, movedlinearly with respect to the first position). The markers 804 on thetool array 612 may move by more than a given amount (e.g., more than 5mm total) from the first frame F1 to the second frame F2. Even with thismovement, the detected distance DD from the tool centerline vector C′ tothe single marker 1018 is substantially identical in both the firstframe F1 and the second frame F2.

Logistically, the surgeon 120 or user could place the tool 608 withinthe guide tube 1014 and slightly rotate it or slide it down into theguide tube 1014 and the system 100, 300, 600 would be able to detectthat the tool 608 is within the guide tube 1014 from tracking of thefive markers (four markers 804 on tool 608 plus single marker 1018 onguide tube 1014). Knowing that the tool 608 is within the guide tube1014, all 6 degrees of freedom may be calculated that define theposition and orientation of the robotic end effector 1012 in space.Without the single marker 1018, even if it is known with certainty thatthe tool 608 is within the guide tube 1014, it is unknown where theguide tube 1014 is located along the tool's centerline vector C′ and howthe guide tube 1014 is rotated relative to the centerline vector C′.

With emphasis on FIG. 15E, the presence of the single marker 1018 beingtracked as well as the four markers 804 on the tool 608, it is possibleto construct the centerline vector C′ of the guide tube 1014 and tool608 and the normal vector through the single marker 1018 and through thecenterline vector C′. This normal vector has an orientation that is in aknown orientation relative to the forearm of the robot distal to thewrist (in this example, oriented parallel to that segment) andintersects the centerline vector C′ at a specific fixed position. Forconvenience, three mutually orthogonal vectors k′, j′, can beconstructed, as shown in FIG. 15E, defining rigid body position andorientation of the guide tube 1014. One of the three mutually orthogonalvectors k′ is constructed from the centerline vector C′, the secondvector j is constructed from the normal vector through the single marker1018, and the third vector is the vector cross product of the first andsecond vectors k′, j′. The robot's joint positions relative to thesevectors k′, j′, are known and fixed when all joints are at zero, andtherefore rigid body calculations can be used to determine the locationof any section of the robot relative to these vectors k′, j′, when therobot is at a home position. During robot movement, if the positions ofthe tool markers 804 (while the tool 608 is in the guide tube 1014) andthe position of the single marker 1018 are detected from the trackingsystem, and angles/linear positions of each joint are known fromencoders, then position and orientation of any section of the robot canbe determined.

In some embodiments, it may be useful to fix the orientation of the tool608 relative to the guide tube 1014. For example, the end effector guidetube 1014 may be oriented in a particular position about its axis 1016to allow machining or implant positioning. Although the orientation ofanything attached to the tool 608 inserted into the guide tube 1014 isknown from the tracked markers 804 on the tool 608, the rotationalorientation of the guide tube 1014 itself in the camera coordinatesystem is unknown without the additional tracking marker 1018 (ormultiple tracking markers in other embodiments) on the guide tube 1014.This marker 1018 provides essentially a “clock position” from −180° to+180° based on the orientation of the marker 1018 relative to thecenterline vector C′. Thus, the single marker 1018 can provideadditional degrees of freedom to allow full rigid body tracking and/orcan act as a surveillance marker to ensure that assumptions about therobot and camera positioning are valid.

FIG. 16 is a block diagram of a method 1100 for navigating and movingthe end-effector 1012 (or any other end-effector described herein) ofthe robot 102 to a desired target trajectory. Another use of the singlemarker 1018 on the robotic end effector 1012 or guide tube 1014 is aspart of the method 1100 enabling the automated safe movement of therobot 102 without a full tracking array attached to the robot 102. Thismethod 1100 functions when the tracking cameras 200, 326 do not moverelative to the robot 102 (i.e., they are in a fixed position), thetracking system's coordinate system and robot's coordinate system areco-registered, and the robot 102 is calibrated such that the positionand orientation of the guide tube 1014 can be accurately determined inthe robot's Cartesian coordinate system based only on the encodedpositions of each robotic axis.

For this method 1100, the coordinate systems of the tracker and therobot must be co-registered, meaning that the coordinate transformationfrom the tracking system's Cartesian coordinate system to the robot'sCartesian coordinate system is needed. For convenience, this coordinatetransformation can be a 4×4 matrix of translations and rotations that iswell known in the field of robotics. This transformation will be termedTcr to refer to “transformation—camera to robot”. Once thistransformation is known, any new frame of tracking data, which isreceived as x,y,z coordinates in vector form for each tracked marker,can be multiplied by the 4×4 matrix and the resulting x,y,z coordinateswill be in the robot's coordinate system. To obtain Tcr, a full trackingarray on the robot is tracked while it is rigidly attached to the robotat a location that is known in the robot's coordinate system, then knownrigid body methods are used to calculate the transformation ofcoordinates. It should be evident that any tool 608 inserted into theguide tube 1014 of the robot 102 can provide the same rigid bodyinformation as a rigidly attached array when the additional marker 1018is also read. That is, the tool 608 need only be inserted to anyposition within the guide tube 1014 and at any rotation within the guidetube 1014, not to a fixed position and orientation. Thus, it is possibleto determine Tcr by inserting any tool 608 with a tracking array 612into the guide tube 1014 and reading the tool's array 612 plus thesingle marker 1018 of the guide tube 1014 while at the same timedetermining from the encoders on each axis the current location of theguide tube 1014 in the robot's coordinate system.

Logic for navigating and moving the robot 102 to a target trajectory isprovided in the method 1100 of FIG. 16. Before entering the loop 1102,it is assumed that the transformation Tcr was previously stored. Thus,before entering loop 1102, in step 1104, after the robot base 106 issecured, greater than or equal to one frame of tracking data of a toolinserted in the guide tube while the robot is static is stored; and instep 1106, the transformation of robot guide tube position from cameracoordinates to robot coordinates Tcr is calculated from this static dataand previous calibration data. Tcr should remain valid as long as thecameras 200, 326 do not move relative to the robot 102. If the cameras200, 326 move relative to the robot 102, and Tcr needs to bere-obtained, the system 100, 300, 600 can be made to prompt the user toinsert a tool 608 into the guide tube 1014 and then automaticallyperform the necessary calculations.

In the flowchart of method 1100, each frame of data collected consistsof the tracked position of the DRB 1404 on the patient 210, the trackedposition of the single marker 1018 on the end effector 1014, and asnapshot of the positions of each robotic axis. From the positions ofthe robot's axes, the location of the single marker 1018 on the endeffector 1012 is calculated. This calculated position is compared to theactual position of the marker 1018 as recorded from the tracking system.If the values agree, it can be assured that the robot 102 is in a knownlocation. The transformation Tcr is applied to the tracked position ofthe DRB 1404 so that the target for the robot 102 can be provided interms of the robot's coordinate system. The robot 102 can then becommanded to move to reach the target.

After steps 1104, 1106, loop 1102 includes step 1108 receiving rigidbody information for DRB 1404 from the tracking system; step 1110transforming target tip and trajectory from image coordinates totracking system coordinates; and step 1112 transforming target tip andtrajectory from camera coordinates to robot coordinates (apply Tcr).Loop 1102 further includes step 1114 receiving a single stray markerposition for robot from tracking system; and step 1116 transforming thesingle stray marker from tracking system coordinates to robotcoordinates (apply stored Tcr). Loop 1102 also includes step 1118determining current location of the single robot marker 1018 in therobot coordinate system from forward kinematics. The information fromsteps 1116 and 1118 is used to determine step 1120 whether the straymarker coordinates from transformed tracked position agree with thecalculated coordinates being less than a given tolerance. If yes,proceed to step 1122, calculate and apply robot move to target x, y, zand trajectory. If no, proceed to step 1124, halt and require full arrayinsertion into guide tube 1014 before proceeding; step 1126 after arrayis inserted, recalculate Tcr; and then proceed to repeat steps 1108,1114, and 1118.

This method 1100 has advantages over a method in which the continuousmonitoring of the single marker 1018 to verify the location is omitted.Without the single marker 1018, it would still be possible to determinethe position of the end effector 1012 using Tcr and to send theend-effector 1012 to a target location but it would not be possible toverify that the robot 102 was actually in the expected location. Forexample, if the cameras 200, 326 had been bumped and Tcr was no longervalid, the robot 102 would move to an erroneous location. For thisreason, the single marker 1018 provides value with regard to safety.

For a given fixed position of the robot 102, it is theoreticallypossible to move the tracking cameras 200, 326 to a new location inwhich the single tracked marker 1018 remains unmoved since it is asingle point, not an array. In such a case, the system 100, 300, 600would not detect any error since there would be agreement in thecalculated and tracked locations of the single marker 1018. However,once the robot's axes caused the guide tube 1012 to move to a newlocation, the calculated and tracked positions would disagree and thesafety check would be effective.

The term “surveillance marker” may be used, for example, in reference toa single marker that is in a fixed location relative to the DRB 1404. Inthis instance, if the DRB 1404 is bumped or otherwise dislodged, therelative location of the surveillance marker changes and the surgeon 120can be alerted that there may be a problem with navigation. Similarly,in the embodiments described herein, with a single marker 1018 on therobot's guide tube 1014, the system 100, 300, 600 can continuously checkwhether the cameras 200, 326 have moved relative to the robot 102. Ifregistration of the tracking system's coordinate system to the robot'scoordinate system is lost, such as by cameras 200, 326 being bumped ormalfunctioning or by the robot malfunctioning, the system 100, 300, 600can alert the user and corrections can be made. Thus, this single marker1018 can also be thought of as a surveillance marker for the robot 102.

It should be clear that with a full array permanently mounted on therobot 102 (e.g., the plurality of tracking markers 702 on end-effector602 shown in FIGS. 7A-7C) such functionality of a single marker 1018 asa robot surveillance marker is not needed because it is not requiredthat the cameras 200, 326 be in a fixed position relative to the robot102, and Tcr is updated at each frame based on the tracked position ofthe robot 102. Reasons to use a single marker 1018 instead of a fullarray are that the full array is more bulky and obtrusive, therebyblocking the surgeon's view and access to the surgical field 208 morethan a single marker 1018, and line of sight to a full array is moreeasily blocked than line of sight to a single marker 1018.

Turning now to FIGS. 17A-17B and 18A-18B, instruments 608, such asimplant holders 608B, 608C, are depicted which include both fixed andmoveable tracking markers 804, 806. The implant holders 608B, 608C mayhave a handle 620 and an outer shaft 622 extending from the handle 620.The shaft 622 may be positioned substantially perpendicular to thehandle 620, as shown, or in any other suitable orientation. An innershaft 626 may extend through the outer shaft 622 with a knob 628 at oneend. Implant 10, 12 connects to the shaft 622, at the other end, at tip624 of the implant holder 608B, 608C using typical connection mechanismsknown to those of skill in the art. The knob 628 may be rotated, forexample, to expand or articulate the implant 10, 12. U.S. Pat. Nos.8,709,086 and 8,491,659, which are incorporated by reference herein,describe expandable fusion devices and methods of installation.

When tracking the tool 608, such as implant holder 608B, 608C, thetracking array 612 may contain a combination of fixed markers 804 andone or more moveable markers 806 which make up the array 612 or isotherwise attached to the implant holder 608B, 608C. The navigationarray 612 may include at least one or more (e.g., at least two) fixedposition markers 804, which are positioned with a known locationrelative to the implant holder instrument 608B, 608C. These fixedmarkers 804 would not be able to move in any orientation relative to theinstrument geometry and would be useful in defining where the instrument608 is in space. In addition, at least one marker 806 is present whichcan be attached to the array 612 or the instrument itself which iscapable of moving within a pre-determined boundary (e.g., sliding,rotating, etc.) relative to the fixed markers 804. The system 100, 300,600 (e.g., the software) correlates the position of the moveable marker806 to a particular position, orientation, or other attribute of theimplant 10 (such as height of an expandable interbody spacer shown inFIGS. 17A-17B or angle of an articulating interbody spacer shown inFIGS. 18A-18B). Thus, the system and/or the user can determine theheight or angle of the implant 10, 12 based on the location of themoveable marker 806.

In the embodiment shown in FIGS. 17A-17B, four fixed markers 804 areused to define the implant holder 608B and a fifth moveable marker 806is able to slide within a pre-determined path to provide feedback on theimplant height (e.g., a contracted position or an expanded position).FIG. 17A shows the expandable spacer 10 at its initial height, and FIG.17B shows the spacer 10 in the expanded state with the moveable marker806 translated to a different position. In this case, the moveablemarker 806 moves closer to the fixed markers 804 when the implant 10 isexpanded, although it is contemplated that this movement may be reversedor otherwise different. The amount of linear translation of the marker806 would correspond to the height of the implant 10. Although only twopositions are shown, it would be possible to have this as a continuousfunction whereby any given expansion height could be correlated to aspecific position of the moveable marker 806.

Turning now to FIGS. 18A-18B, four fixed markers 804 are used to definethe implant holder 608C and a fifth, moveable marker 806 is configuredto slide within a pre-determined path to provide feedback on the implantarticulation angle. FIG. 18A shows the articulating spacer 12 at itsinitial linear state, and FIG. 18B shows the spacer 12 in an articulatedstate at some offset angle with the moveable marker 806 translated to adifferent position. The amount of linear translation of the marker 806would correspond to the articulation angle of the implant 12. Althoughonly two positions are shown, it would be possible to have this as acontinuous function whereby any given articulation angle could becorrelated to a specific position of the moveable marker 806.

In these embodiments, the moveable marker 806 slides continuously toprovide feedback about an attribute of the implant 10, 12 based onposition. It is also contemplated that there may be discreet positionsthat the moveable marker 806 must be in which would also be able toprovide further information about an implant attribute. In this case,each discreet configuration of all markers 804, 806 correlates to aspecific geometry of the implant holder 608B, 608C and the implant 10,12 in a specific orientation or at a specific height. In addition, anymotion of the moveable marker 806 could be used for other variableattributes of any other type of navigated implant.

Although depicted and described with respect to linear movement of themoveable marker 806, the moveable marker 806 should not be limited tojust sliding as there may be applications where rotation of the marker806 or other movements could be useful to provide information about theimplant 10, 12. Any relative change in position between the set of fixedmarkers 804 and the moveable marker 806 could be relevant informationfor the implant 10, 12 or other device. In addition, although expandableand articulating implants 10, 12 are exemplified, the instrument 608could work with other medical devices and materials, such as spacers,cages, plates, fasteners, nails, screws, rods, pins, wire structures,sutures, anchor clips, staples, stents, bone grafts, biologics, cements,or the like.

Turning now to FIG. 19A, it is envisioned that the robot end-effector112 is interchangeable with other types of end-effectors 112. Moreover,it is contemplated that each end-effector 112 may be able to perform oneor more functions based on a desired surgical procedure. For example,the end-effector 112 having a guide tube 114 may be used for guiding aninstrument 608 as described herein. In addition, end-effector 112 may bereplaced with a different or alternative end-effector 112 that controlsa surgical device, instrument, or implant, for example.

The alternative end-effector 112 may include one or more devices orinstruments coupled to and controllable by the robot. By way ofnon-limiting example, the end-effector 112, as depicted in FIG. 19A, maycomprise a retractor (for example, one or more retractors disclosed inU.S. Pat. Nos. 8,992,425 and 8,968,363) or one or more mechanisms forinserting or installing surgical devices such as expandableintervertebral fusion devices (such as expandable implants exemplifiedin U.S. Pat. Nos. 8,845,734; 9,510,954; and 9,456,903), stand-aloneintervertebral fusion devices (such as implants exemplified in U.S. Pat.Nos. 9,364,343 and 9,480,579), expandable corpectomy devices (such ascorpectomy implants exemplified in U.S. Pat. Nos. 9,393,128 and9,173,747), articulating spacers (such as implants exemplified in U.S.Pat. No. 9,259,327), facet prostheses (such as devices exemplified inU.S. Pat. No. 9,539,031), laminoplasty devices (such as devicesexemplified in U.S. Pat. No. 9,486,253), spinous process spacers (suchas implants exemplified in U.S. Pat. No. 9,592,082), inflatables,fasteners including polyaxial screws, uniplanar screws, pedicle screws,posted screws, and the like, bone fixation plates, rod constructs andrevision devices (such as devices exemplified in U.S. Pat. No.8,882,803), artificial and natural discs, motion preserving devices andimplants, spinal cord stimulators (such as devices exemplified in U.S.Pat. No. 9,440,076), and other surgical devices. The end-effector 112may include one or instruments directly or indirectly coupled to therobot for providing bone cement, bone grafts, living cells,pharmaceuticals, or other deliverable to a surgical target. Theend-effector 112 may also include one or more instruments designed forperforming a discectomy, kyphoplasty, vertebrostenting, dilation, orother surgical procedure.

The end-effector itself and/or the implant, device, or instrument mayinclude one or more markers 118 such that the location and position ofthe markers 118 may be identified in three-dimensions. It iscontemplated that the markers 118 may include active or passive markers118, as described herein, that may be directly or indirectly visible tothe cameras 200. Thus, one or more markers 118 located on an implant 10,for example, may provide for tracking of the implant 10 before, during,and after implantation.

As shown in FIG. 19B, the end-effector 112 may include an instrument 608or portion thereof that is coupled to the robot arm 104 (for example,the instrument 608 may be coupled to the robot arm 104 by the couplingmechanism shown in FIGS. 9A-9C) and is controllable by the robot system100. Thus, in the embodiment shown in FIG. 19B, the robot system 100 isable to insert implant 10 into a patient and expand or contract theexpandable implant 10. Accordingly, the robot system 100 may beconfigured to assist a surgeon or to operate partially or completelyindependently thereof. Thus, it is envisioned that the robot system 100may be capable of controlling each alternative end-effector 112 for itsspecified function or surgical procedure.

Although the robot and associated systems described herein are generallydescribed with reference to spine applications, it is also contemplatedthat the robot system is configured for use in other surgicalapplications, including but not limited to, surgeries in trauma or otherorthopedic applications (such as the placement of intramedullary nails,plates, and the like), cranial, neuro, cardiothoracic, vascular,colorectal, oncological, dental, and other surgical operations andprocedures.

During robotic spine (or other) procedures, a Dynamic Reference Base(DRB) may thus be affixed to the patient (e.g., to a bone of thepatient), and used to track the patient anatomy. Since the patient isbreathing, a position of the DRB (which is attached to the patient'sbody) may oscillate. Once a surgical tool is robotically moved to atarget trajectory and locked into position, patient movement (e.g., dueto breathing) may cause deviation from the target trajectory eventhrough the end-effector (e.g., surgical tool) is locked in place. Thisdeviation/shift (if unnoticed and unaccounted for) may thus reduceaccuracy of the system and/or surgical procedure.

During the process of inserting a needle or electrode into the brainunder guidance, it may be important that the brain does not move (evenslightly) relative to the guide tube used to guide insertion of theneedle or electrode. Methods are disclosed herein to prepare the skullunder robotic guidance and then to deliver a precise temporary needleguide fixture to mount to the skull using robotic guidance. Then, withthe robot set aside, the needle is inserted with reference only to thetemporary guide fixture. Since the temporary guide fixture is fixedrelative to the skull, there should be reduced risk of brain injuryshould the patient move during needle insertion.

According to some embodiments, robotic guidance may be used to preparethe skull, and a temporary guide fixture (also referred to as a cranialinsertion fixture) may be attached to the prepared skull. A needle (orother medical device) may then be inserted into the brain through thetemporary guide fixture without further assistance from the robot. Ifthe patient were to twitch during preparation of the skull or deliveryor attachment of the temporary device, little/no damage to brain tissuewould occur. If the patient were to twitch during insertion of theelectrode through the temporary device, reduced/no relative movement ofthe device/needle relative to the brain would occur, and so again,reduced/no damage to brain tissue would occur.

Such a temporary guide fixture may need to be delivered to itsattachment point on the skull and attached without the process ofattachment causing substantial shift in its position. The temporaryguide fixture should be stable in its interface with the skull duringthe time of its usage. A design for such a temporary guide fixture 2105is shown in FIG. 21 according to some embodiments of inventive concepts.In some embodiments, the temporary guide fixture 2105 may allow someadjustability after it has been mounted to the skull 2103, and after atracking element 2115 (also referred to as a tracking array) has beenattached to it.

FIG. 21 shows the skull 2103 with a temporary cranial insertion fixture2105 (also referred to as a temporary guide fixture, temporary needleguide/structure, or temporary electrode guide/structure) attached to theskull 2103 with screw anchors 2101 and including a guide tube 2107. Thedistal end of guide tube 2107 (adjacent base 2121 of the fixture) restsin a recess 2103 a in the skull 2103 for stability. A central holethrough guide tube 2107 is used to guide insertion of a medical device2109 (such as a needle or electrode). The guide tube 2107 may have someangular adjustability through 2 or more telescoping adjustment members2111 and/or a moveable coupling 2127 to compensate for alterations in adesired trajectory after attachment or shift in tube position occurringduring the attachment process. According to some embodiments, guide tube2107 may be coupled with base 2121 of the cranial insertion fixture 2105using a moveable coupling 2127 such as a spherical joint to allowangular movement of guide tube 2107 relative to base 2121. A trackingarray 2115 may allow tracking of the tube position and trajectory onceit is mounted to the skull 2103, providing additional feedback on thefinal position of the temporary needle guide tube 2107. Tracking arraysare discussed above, for example, with respect to tracking array 612.

A process to prepare the skull 2103 to receive the cranial insertionfixture 2105 (also referred to as a temporary needle guide fixture) ofFIG. 21 may include the robotic guidance system registering, planning,and auto-positioning the robotic end effector 2201 of FIG. 22 at aposition adjacent to the skull 2103 where the robot's end effector 2201can position drill guide fixture 2203 as shown in FIG. 22. This drillguide fixture 2203 may allow guided drilling of the central hole (shownas recess 2103 a of FIG. 21) and pilot holes 2205 a-b used to holdanchor screws 2103 a-b of FIG. 21 for the cranial insertion fixture 2105of FIG. 21. The central drill guide 2207 may allow the central burr hole(shown as recess 2013 a of FIG. 21) to be drilled partially through orfully through the skull 2103. A partial instead of complete burr holemay allow delivery of cranial insertion fixture 2105 to the skull 2103and secure attachment of cranial insertion fixture 2105, after which asecond drill with a smaller bit could be guided by the guide tube 2107of cranial insertion fixture 2105 (instead of the robot) to create aburr hole 2103 b all the way through the skull 2103. Since cranialinsertion fixture 2105 (which may also serve as a drill guide for thissmaller diameter secondary through-hole 2103 b) is navigated, thesecondary drill may operate in conjunction with an adjustable drill stopto provide that the secondary drill penetrates exactly to the thicknessof the skull 2103 without over-penetration (which could damage thebrain).

Drill guide fixture 2203 may thus be configured to prepare skull 2103for attachment of cranial insertion fixture 2105. As shown in FIG. 22,drill guide fixture 2203 may include central drill guide 2207 defining acentral drill guide hole therethrough, with the central drill guide holehaving a first opening 2225 at a base of the drill guide fixture and asecond opening 2227 spaced apart from the base of the drill guidefixture. As further shown in FIG. 22, drill guide fixture 2203 mayinclude a bone anchor drill guide 2229 at the base of drill guidefixture 2203, with the bone anchor drill guide 2229 defining a pluralityof (e.g., at least three) bone anchor drill guide holes 2211therethrough spaced around the bone anchor drill guide 2229. Accordingto some embodiments, the bone anchor drill guide 2229 may be provided asa ring (or other geometry/shape) surrounding central drill guide 2207,and each bone anchor drill guide hole 2211 may be offset from thecentral drill guide hole in a direction that is perpendicular withrespect to a direction of the central drill guide hole. In theorientation of FIG. 22, the central drill guide hole is oriented in avertical direction, and each of the bone anchor drill guide holes ishorizontally offset relative to the central drill guide hole. Moreover,each bone anchor drill guide hole 2211 may correspond to a respectivehole in base 2121 of cranial insertion fixture 2105 for screws 2101, sothat holes in base 2121 of cranial insertion fixture 2105 match withrespective pilot holes 2205 drilled using bone anchor drill guide holes2211.

As further shown in FIG. 22, rotational coupling 2210 (e.g., arotational bearing) may be provided between central drill guide 2207 andbone anchor drill guide 2229 so that bone anchor drill guide 2229 isrotatable relative to the central drill guide. The central drill guidehole and each of the bone anchor drill guide holes may be cylindrical.Moreover, an axis of rotation of bone anchor drill guide 2229 may beparallel (e.g., coincident) with respect to an axial direction of thecentral drill guide hole. In addition, a first opening of each boneanchor drill guide hole 2211 adjacent the base of drill guide fixture2207 may be closer to the central drill guide hole than a second openingof the respective bone anchor drill guide hole spaced apart from thebase of the drill guide fixture. Accordingly, each bone anchor drillguide hole 2211 may be non-parallel with respect to central drill guidehole 2227.

As further shown in FIG. 22, a width (e.g., diameter) of the centraldrill guide hole may be greater than widths (e.g., diameters) of boneanchor drill guide holes 2211. According to some embodiments, centraldrill guide hole and bone anchor drill guide holes may be cylindrical.In addition, a connector 2231 may be configured to provide a detachablecoupling with an end effector 2201 of a robotic actuator.

FIG. 20 is a block diagram illustrating elements of a controller 2000(e.g., implemented within computer 408 and/or computer subsystem) for arobotic surgical system. As shown, controller 2000 may include processorcircuit 2007 (also referred to as a processor) coupled with inputinterface circuit 2001 (also referred to as an input interface), outputinterface circuit 2003 (also referred to as an output interface),control interface circuit 2005 (also referred to as a controlinterface), and memory circuit 2009 (also referred to as a memory). Thememory circuit 2009 may include computer readable program code that whenexecuted by the processor circuit 2007 causes the surgical roboticsystem to perform operations according to embodiments disclosed herein.According to other embodiments, processor circuit 2007 may be defined toinclude memory so that a separate memory circuit is not required.

As discussed herein, operations of a surgical robotic system may beperformed by controller 2000 (including processor 2007, input interface2001, output interface 2003, and/or control interface 2005). Forexample, processor 2007 may receive user input through input interface2001, and such user input may include user input received through footpedal 544, tablet 546, etc. Processor 2007 may also receive positionsensor input from tracking system 532 and/or cameras 200 through inputinterface 2001. Processor 2007 may provide output through outputinterface 2003, and such output may include information to rendergraphic/visual information on display 304 and/or audio output to beprovided through speaker 536. Processor 2007 may provide robotic controlinformation through control interface 2005 to motion control subsystem506, and the robotic control information may be used to controloperation of a robotic actuator such as robot arm 104 (also referred toas a robotic arm) and/or end-effector 112 (shown as end effector 2201 inFIG. 22). Processor 2007 may also receive feedback information throughcontrol interface 2005. Operations of a surgical robotic system(including a robotic actuator configured to position a surgicalend-effector and/or a drill guide fixture 2203 with respect to ananatomical location of a patient (such as skull 2103) will be discussedbelow according to some embodiments of inventive concepts. For example,modules may be stored in memory 2009 of FIG. 20, and these modules mayprovide instructions so that when the instructions of a module areexecuted by processor 2007, processor 2007 controls the robotic actuatorand/or end effector to perform respective operations.

According to some embodiments of FIG. 22, a surgical robotic system mayinclude the drill guide fixture 2203 coupled with the robotic actuator,such as a robotic arm 104 through end effector 2201. As discussed above,drill guide fixture 2203 may be configured to prepare a skull forattachment of a cranial insertion fixture 2105 (shown in FIG. 21) thatis used to insert a medical device (such as a needle and/or electrode)through the skull and into a brain. Elements of drill guide fixture 2203are discussed above with respect to FIG. 22. The robotic actuator (e.g.,robotic arm 104) may be defined to include end effector 2201, and drillguide fixture 2203 may be detachably coupled with the robotic actuatorand/or end effector 2201. Moreover, the robotic actuator may beconfigured to position drill guide fixture 2203. Controller 2000 (e.g.,including processor 2007, memory 2009, control interface 2005, etc.) maybe coupled with the robotic actuator as discussed above (e.g., throughcontrol interface 2005), and controller 2003 may be configured tocontrol the robotic actuator to move drill guide fixture 2003 to skull2103 based on medical imaging information related to the skull and/orthe brain and based on a planned trajectory for insertion of the medicaldevice into the brain.

With drill guide fixture 2203 robotically positioned as discussed abovebased on a planned trajectory for the medical device (e.g., a needle oran electrode), the doctor can insert an appropriate drill and/or drillbit 2241 through the central drill guide 2207 to drill the central holein skull 2103 as shown in FIG. 22. The doctor can insert an appropriatedrill and/or drill bit (e.g., smaller than drill bit 2241) through boneanchor drill guide holes 2211 to drill the pilot holes 2205 to be usedfor bone anchor screws 2101. By providing a rotational coupling 2210between bone anchor drill guide 2229 and central drill guide 2207, thedoctor may rotate the bone anchor drill guide 2229 to orient the anchordrill guide holes 2211 (and resulting pilot holes 2205) in a desiredlocation on the skull. Once the doctor has rotated the bone anchor drillguide 2229 to a desired orientation, a locking mechanism may be used tolock the orientation of the bone anchor drill guide 2229 relative to thecentral drill guide 2207 so that the bone anchor drill guide 2229 doesnot move while using bone anchor drill guide holes 2211 to drill pilotholes 2205 into skull 2103. Bone anchor drill guide holes 2211 are thusarranged to provide pilot holes 2205 in skull 2103 that match holes inbase 2121 of fixture 2105 for screws 2101. Accordingly, rotation of boneanchor drill guide 2229 may be locked before drilling pilot holes 2205to maintain an appropriate orientation of pilot holes 2205 relative toeach other.

Once the robotically placed drill guide fixture 2203 has been used todrill the central and pilot holes as discussed above, the roboticactuator, end effector, and drill guide fixture can be moved away fromthe skull to allow attachment of cranial insertion fixture 2105 usingthe central and pilot holes. As shown in FIG. 21, screws 2101 may beprovided through base 2121 and into pilot holes 2205 to secure cranialinsertion fixture 2105 to skull 2103, and a base of guide tube 2107 maybe seated in recess 2103 a (formed using drill 2241 and central guidetube 2207). According to some embodiments, adhesive pads may be usedinstead of screws 2101 to secure base 2121 to skull 2103. According tosome other embodiments, guide tube 2107 may be anchored to skull 2103 atrecess 2103 a so that screws 2101 are not needed to secure base 2121 toskull 2103. In such embodiments, screws 2101 may be omitted, or screws2101 may be provided to push against the skull (without penetrating theskull) to adjust an orientation of guide tube 2107 (e.g., providingdifferent spacings between different locations of base 2121 and skull2103).

After delivering cranial insertion fixture 2105 and attaching it to theskull 2103, the needle guide tube 2107 may require further trajectoryadjustment due to some shift in tube position during the insertionprocess or due to the surgeon changing the desired trajectory. The exactposition of the mounted temporary needle guide device may be knownbecause it has an attached tracking array 2115 and this array is trackedrelative to a previously attached and registered DRB. An adjustmentmechanism may be provided that is part of the temporary needle guidefixture 2105 of FIG. 21. It may only be necessary for such an adjustmentmechanism to allow small adjustments. If large adjustments are needed, adifferent through hole and anchor pilot holes may be drilled, and theentire needle guide device may be repositioned. In embodiments of FIG.21, the adjustment mechanism may include telescoping adjustment membersallowing only angulation of the tube. The adjustment mechanism may alsoenable linear shifts in the position of the tube. The adjustmentmechanism may thus include one or more different telescoping,angulating, or otherwise adjustable members/mechanisms 2111 that theuser can independently adjust according to instruction from the softwareand/or while watching feedback from the optical tracking. The adjustablemembers/mechanisms 2111, for example, may be electrically and/orhydraulically actuated members operating under the control of controller2000 based on optical feedback from cameras 200 using tracking array2115, medical image information (e.g., a CT scan or MM) for skull 2103and brain 2141, and/or a planned trajectory for the medical device.

Cranial insertion fixture 2105 may thus be configured to provideguidance to insert a medical device (e.g., a needle and/or an electrode)into brain 2141. As shown, cranial insertion fixture 2105 may includebase 2121, guide tube 2107, moveable coupling 2127, and adjustmentmember(s) 2111. Base 2121 may include a plurality of spaced apartcontact areas configured to provide contact with skull 2103 and aplurality of spaced apart anchor screw holes for screws 2101. The screwholes, for example, may be provided at respective contact areas.

Guide tube 2107 may be coupled with base 2121, with guide tube 2107including a contact end and an insertion end. Moreover, the contact endmay be configured to contact an opening 2103 a in skull 2103, and theinsertion end (spaced apart from skull 2103) may be configured toreceive medical device 2109. In addition, moveable coupling 2127 may beprovided between base 2121 and a first portion of guide tube 2107, andadjustment member(s) 2111 may be coupled between base 2121 and a secondportion of guide tube 2107. Moreover, moveable coupling 2127 may be aspherical joint configured to allow angular movement of the guide tube2107 relative to base 2121.

According to some embodiments, three adjustment members 2111 may beprovided, and each adjustment member may include at least threetelescoping adjustment members coupled between base 2121 and the secondportion of guide tube 2107. Moreover, the telescoping adjustment membersmay be configured to lock the guide tube in different angularorientations relative to the base. Each adjustment member may comprise atelescoping actuator (e.g., a manually, electrically, and/orhydraulically actuated actuator) configured to move guide tube 2017 todifferent angular orientations relative to base 2121. According to someembodiments, such actuators may be controlled by controller 2000 toautomatically set a trajectory of guide tube 2017 based on medicalimaging information, positioning information determined using trackingarray 2115 coupled with guide tube 2107, and/or a planned trajectory.

FIG. 22 shows robotic positioning of a drill guide 2203 to prepare theskull 2103 to receive cranial insertion fixture 2105. The central drillguide 2207 guides drilling of the main hole (shown as recess 2103 a inFIG. 21) through which the needle is to be inserted. The purpose of thebone anchor drill guide holes 2211 is to guide drilling of the pilotholes 2205 a and 2205 b for the bone anchor screws 2101 that holdcranial insertion fixture 2105 attached to the skull 2103. In thisembodiment, the bone anchor drill guide 2229 may include three or morebone anchor drill guide holes 2211, and bone anchor drill guide 2229 maybe connected to central drill guide 2207 by a rotational bearing 2210 sothat the holes 2205 can be rotationally positioned where desired in/onskull 2103 relative to the central hole 2103 a.

According to some embodiments discussed with respect to FIGS. 23-26,cranial electrode and/or needle insertion can be performed withoutrequiring a pin-based skull frame to be attached, thereby reducing themorbidity of the procedure. Moreover, cranial electrode and/or needleinsertion may be performed using robotic assistance instead of requiringan attached arc mechanism, increasing the speed and/or accuracy of theprocedure.

Positioning of implants may currently use a relatively large burr holethrough the cranium/skull, often over 14 millimeters in diameter. Byusing a hole of this size, the surgery may no longer be consideredminimally invasive surgery (MIS). Additionally, the large size of thehole may provide an avenue for leakage of Cerebrospinal Fluid (CSF).Leakage of this fluid may cause a change in pressure in the skull and/ora shift of the brain within the skull. Such hole sizes may also requirea cosmetically undesirable implant to cover the hole after electrodeplacement.

Embodiments of inventive concepts may combine methods of implantguidance and locking mechanisms to accurately guide an electrode implantto a target location in the brain while simultaneously plugging the holein order to reduce/prevent leaks, all while using a small enoughincision to be considered MIS. According to such embodiments, thesurgeon may insert a medical device (e.g., electrode) through a smallerhole, and secure the hole with better cosmesis while also plugging thehole to reduce pressure change and brain shift. According to some otherembodiments, an electrode may be inserted after a robotic positioner hasbeen removed.

In current methods of brain electrode placement, the electrode and itsretaining implant may be inserted through a large burr hole in theskull. The large burr hole (often 14 mm or more in diameter) may beuseful to allow the electrode position to be adjusted during surgery.However, once the electrode is in place, a permanent cover may need tobe implanted to hold the electrode in its final location relative to theskull, clamping the wire to prevent it from moving, while allowing theextracranial portion of the wire to be routed subcutaneously. Asdiscussed above, such implants may be cosmetically undesirable.

Current implant retention designs may thus be bulky and may thus requirea large patch of hair to be shaved for the procedure. Moreover, theimplant cover may leave a bump under the scalp after healing if carefulmilling is not performed.

According to some embodiments of inventive concepts, it may be possibleto insert electrodes through a smaller hole (than has been used forconventional procedures) due to the high accuracy of a surgical robotand more flexible positioning range. The smaller hole may leave asmaller gap between the electrode and the edge of the burr hole, whichmay allow the electrode attachment device to be smaller. In someembodiments, the implant may also effectively seal the skull andreduce/prevent changes in pressure and/or CSF leaks.

FIG. 23 is a cross sectional view illustrating an electrode retentionimplant according to some embodiments of inventive concepts. As shown,the electrode retention implant may be placed in a hole through theskull (also referred to as the cranium). The threaded exterior 2311 ofthe mechanism allows for grip once in the skull and stability once fullyinstalled. As shown, the guidance mechanism may include housing 2303,compressible insert bushing 2305, strain relief cap 2307, and o-ring2309. The guidance mechanism of FIG. 23 may thus be used to guideinsertion of a medical device (such as electrode 2315 or a needle) intothe brain. After planning a desired electrode trajectory on thepatient's medical image volumes (MRI and/or CT image volumes), therobotic system may automatically move into place and hold a guide tubein the planned trajectory, positioned just above the skull, similar tomethods used with robotic screw placement in the spine. Through therobotically positioned guide tube (not shown), the surgeon may drill ahole through the skull. Then, the surgeon may insert the electroderetention implant into the hole in the skull.

In some embodiments, the burr hole in the skull may be tapped to leavethreads that can engage corresponding threads of the electrode retentionimplant. In some other embodiments, the bone may be left untapped, andthe threads of the electrode retention implant may be self-cutting. Instill other embodiments, the burr hole may be left untapped, and theelectrode retention implant may be fastened in the skull usingperipheral set screws, or by gluing, crimping, and/or clamping into theskull.

When the electrode retention implant is fastened to the skull, a primaryfluid pathway may be through its center hole (through which theelectrode will pass). Although a secondary fluid pathway may be possiblealong an outer edge of the implant where it interfaces with the skull,o-ring 2309 (e.g., comprising a biocompatible and possibly resorbableelastomeric material) may help to seal this outer portion toreduce/prevent fluid leakage. In other embodiments, a layer of geland/or paste may be used instead of or in addition to the o-ring to helpseal an outer portion of the skull-implant interface. The center holemay be concentric with respect to the electrode and may house thelocking electrode retention mechanism.

FIG. 23 is a cross sectional view illustrating the electrode retentionimplant placed in a hole in the skull. The threaded exterior 2311 of theimplant allows for grip with the skull and stability once fullyinstalled. The O-ring 2309 helps seal the implant-bone interface. Thestrain relief cap 2307 is a sliding metal piece that compresses theinsert bushing 2305 when forced downward. Note that the strain reliefcap 2307 has a larger inside diameter than the outside diameter of theelectrode so that it does not force the electrode 2315 to advance whenmoved downward. The insert bushing 2305 may be made of an elastomericmaterial such that when it is compressed by the strain relief cap 2307,it expands toward the center of the hole (toward electrode 2315)gripping the electrode without causing it to advance.

The electrode retention implant may be detachably interconnected with anelectrode guidance tube 2403 as shown in FIG. 24, and the electrodeguidance tube 2403 may be used to insert the electrode retention implant(shown at the bottom of tube 2403 in FIG. 24), for example using theelectrode guidance tube 2403 as a screwdriver, and to guide passage ofthe electrode concentrically along a desired trajectory. Alternatively,two separate tools may be used. For example, a first driver tool may beused to insert the electrode retention implant, and then an electrodeguide tube may be connected to the electrode retention implant and usedto guide the passage of the electrode along the desired trajectory. Insome embodiments, the electrode guidance tube may have threads locatedbottom of the chamfer that interlock with threads in the chamfered topedges of the electrode retention implant. The electrode itself may thenbe inserted through the wire guide to its desired depth. Once theelectrode is in place, a mechanism may be deployed that forces thestrain relief cap downward (toward/into the skull), compressing thebushing that retains the electrode.

In some embodiments, the electrode retention device may also have a setscrew mechanism proximal to the strain relief cap 2307 so that when theset screw is advanced, the strain relief cap 2307 is forced downward(toward/into the skull), compressing insert bushing 2305. The set screwmay be left in place as part of the implant to keep the insert bushingcompressed. In other embodiments, a plunger within the electrodeguidance tube may be forced down to force the distal strain relief capdownward (toward/into the skull) and to compress the insert bushing2305. While held in this configuration, another mechanism may deployglue, a crimper, and/or an additional set screw to hold the insertbushing in its compressed state.

As shown in FIG. 24, electrode 2315 may be inserted through theelectrode guidance tube and electrode retention implant. The electrodeguidance tube may rest in and be rigidly connected with the chamfer ofthe electrode retention implant.

After the electrode retention implant and the electrode 2315 are inplace and secured, the electrode guidance tube may be removed. Thesurgeon may then tunnel the implanted electrode 2315 subcutaneously awayfrom the burr hole as shown in FIG. 25. The chamfered edge may provide agentle transition for the electrode to reduce/prevent damage to the wirewhen laid flat against the skull as shown in FIG. 25. A pathway for theelectrode wire may be that once the electrode retention implant and theelectrode are in place, the electrode wire may travel under the skinfrom the implant location, behind the patient's ear, down the shoulderand into the chest adjacent to the clavicle.

FIG. 25 shows that the electrode wire may pass through the electroderetention implant and curve gradually as it bends 90 degrees to lieflush with the skull after the guide tube has been removed and the gapbetween the implant and the electrode is sealed. The chamfered oralternately rounded edge may allow a more gradual bend than a plainhole, thereby reducing/preventing wear of the locking mechanism of theimplant over time.

According to other embodiments, a cannula may be put in place to guidethe electrode to a proper position in the brain. The workflow for such aprocess may be provided as follows. The surgeon may insert the electroderetention implant then insert the cannula to the desired depth. To makethe cannula stiffer and reduce/prevent fluid from entering into it, thecannula may be occupied with a stylet (stiff wire) at the time ofinsertion. With the cannula and stylet inserted the bushing may betemporarily compressed to hold the cannula. The surgeon may then removethe stylet from the cannula and insert the electrode wire in place ofthe stylet. Once the electrode is positioned correctly, the surgeon willrelease compression on the bushing, remove the cannula, and finallyre-lock the bushing to the electrode.

In another embodiment of the electrode guidance tube, the temporarilyattached tube is used without further robotic assistance to position theelectrode to its final depth. An advantage of such a method may be thatthe robot and stereotactic frame may be out of the way of the surgeonand imaging equipment, and the patient may be taken from the operatingroom to a different room/facility (such an and imaging suite for MMand/or CT imaging) that might allow better visualization of structuresof the brain relative to the electrode tip and facilitate furtheradjustment of electrode position with the patient awake or asleep. Sucha method may require that the electrode guidance tube remain rigidly inthe desired trajectory relative to the skull. The method may thereforerequire rigid interlocking of the electrode retention implant to theskull and rigid interlocking of the electrode guidance tube to theelectrode retention implant as shown in FIG. 24.

Another embodiment may include an additional stabilizing mechanismoutside the diameter of the electrode guidance tube as shown in FIG. 26to further provide that the electrode guidance tube 2315 is maintainedin the desired trajectory. Such a stabilizing mechanism may include aplurality of at least three legs 2601 or an extended rim with anadjustment mechanism to allow the stabilizers (e.g., legs) to pressagainst the skull with light force to maintain the static trajectory ofthe guidance tube.

FIG. 26 illustrates a cutaway side view showing an outrigger mechanismon the electrode guidance tube to maintain the tube's trajectory in astatic position relative to the skull after the robotically controlledalignment tube is removed. One or more outrigger legs 2601 may hold thetube in a static position, with three legs providing a desiredstability, like a tripod. Legs 2601 may be provided with respectiveadjustment mechanisms to adjust a pressure of each foot against theskull.

By locking the electrode in place through a small hole, embodiments ofinventive concepts may offer a better alternative for brain electrodeplacement surgery. Such embodiments may reduce CSF leakage due tosmaller burr hole size and a more effective/immediate sealing of thehole. The guide may fasten immediately to the skull when inserted ratherthan requiring additional fasteners to secure. Moreover, final electrodeinsertion or adjustment may be performed using just the implant and theelectrode guide without the robot arm or head frame present, meaningthat the patient can be more easily transferred out of the operatingroom (i.e., to an MRI or other imaging equipment) to finalize electrodeplacement.

According to some embodiments discussed below with respect to FIGS.27-31, robotic surgery may be provided without requiring optical and/orelectromagnetic tracking of the patient and robot. Such methods may besuited to cranial procedures such as deep brain stimulation DBSelectrode placement.

A floor-mounted 5-axis robot may provide (according to the coordinatesystem of FIG. 27), in order from base to extremity, a vertical linearz-axis followed by rotation about the Z axis at a shoulder joint,followed by a second rotation about the Z axis at an elbow jointconnecting upper to lower arm, followed by roll about the lower armfollowed by pitch at a wrist joint, with an end effector distal to thewrist joint. Such a robot can be utilized in a mode that does notrequire optical tracking of the robot or patient. In such a mode, therobot's base coordinate system may be registered directly to theanatomy.

If the robot is well calibrated, it may be possible to determine aposition of the end effector based on the positions of each robotic axis(forward kinematics) and to determine the position of each robotic axisused to drive the end effector to a target location and trajectory(inverse kinematics). In the exemplary 5-axis robot mentioned above, ifthe current dynamic location of each axis is known through, for example,encoders or Hall Effect sensors on the motor of each axis, and if eachangular joint rotates in a truly planar fashion, the linear z-axistravels in a truly linear fashion, and manufactured segment lengths andrelative joint face angles are accurately known, then forward kinematicscan be used to precisely determine the location of the guide tube heldby the end effector. Similarly, to drive the robot to where the guidetube on the end effector is in the desired location and orientation,inverse kinematics can be used to calculate the necessary position tosend each joint dynamically.

This ability to detect the current end-effector position or drive theposition of the end-effector to a desired location can be generalized toan n-axis robot. Desired locations and trajectories in the surgicalspace may be referenced via a Cartesian coordinate system to the frameon the patient as shown in FIG. 27. Using inverse kinematics, thelocations to which each joint should be driven to position the endeffector at the desired tip location with the desired trajectory can bedetermined. Once each joint location is known, the final step is todetermine the actuator location that is required to accurately set thejoint location. This consideration may be nontrivial given the manydifferent types of actuator designs, which can include linear, rotary,coupled, and non-linear to name a few. For example, a linear actuatorcould attach to a lever on one side of an angular joint to create anangular movement of the joint, and the required precise actuatorposition to achieve the desired joint angle should be properlycalibrated.

In methods according to some embodiments of inventive concepts,registration may be performed by moving the robot's end effector intoposition over known landmarks on a patient-mounted reference fixturethat is simultaneously rigidly affixed to the patient and the robotbase, then automatically sampling the positions of the robot's jointsfrom encoders on each axis and using forward kinematics to determine thelocations of the landmarks in the robot's base coordinate system. Thisprocedure may register a head frame relative to the robot coordinatesystem. Registration of a head frame relative to the anatomicalcoordinate system is achieved since the reference fixture also containsradio-opaque fiducials in known positions relative to the head frame.These fiducials are detected in the CT scan and their locationsautomatically determined through image processing. With the robotregistered relative to the head frame and anatomy registered relative tothe head frame, the robot is registered relative to the anatomy. Thehead frame to which the reference fixture was attached remains rigidlyaffixed to the patient and robot base for the remainder of theprocedure, and so the robot remains registered to patient anatomy aslong as this rigid interconnection persists. The surgical procedure canthen be completed robotically as is currently done through existingmethods using optical tracking.

In cranial procedures, such a reference fixture may include a localizer,such as the N-shaped localizer currently used with the Leksell frame,with additional registration features, as shown in FIGS. 28A, 28B, 28C,and 28D. This reference fixture of FIG. 28B would temporarily mount tothe frame of FIG. 28A that is pinned into the patient's skull in FIGS.28C and 28D, which would itself attach to the robot base (via the arm ofFIGS. 28A, 28C, and 28D) to provide rigidity of the frame relative tothe robot.

Alternately, the localizer fixture of FIG. 29A and a separate robotreference fixture of FIG. 29B with posts, holes, balls, or sockets maybe used sequentially as shown in FIGS. 29C and 29D as long as theyanchor to specific locations with a fixed offset relative to the headframe and each other as shown in FIGS. 29A, 29B, 29C, and 29D. Forexample, the localizer fixture (with N-shaped fiducial rods) of FIG. 29Acould connect to the head frame as shown in FIG. 29C before collectingthe CT scan. After collecting the CT scan, the localizer fixture couldbe removed and a robot reference fixture of FIG. 29B with posts could besecured to the frame as shown in FIG. 29D using the same mount points asthe localizer fixture. The robot would then be registered by touchingthe reference points on the robot reference fixture with the robot's endeffector. Alternately, the order could be reversed. That is, theregistration of robot to head frame could be performed first by movingthe robot to touch points on the robot reference fixture, then the robotreference fixture removed, the CT reference fixture attached, and a CTcollected. In either case, after performing robot and CT registration,both fixtures would be removed, leaving just the head frame.

FIGS. 28A-D shows a head frame (e.g., Leksell) and a reference fixture.FIG. 28A illustrates a head frame with a rigid arm that secures it tothe robot base. Four threaded pins are visible to secure the head frameto the patient's head. FIG. 28B illustrates a reference fixture withfiducial rods in an N shape to allow CT registration as is currentlyperformed using Leksell frame localizer. In addition, FIG. 28B showsposts that allow robot registration. FIG. 28C shows the frame of FIG.28A mounted on a patient's head, and FIG. 28D shows the frame of FIG.28A and the reference fixture of FIG. 28B mounted on the patient's head.

FIGS. 29A, 29B, 29C, and 29D show an alternative sequential method usingtwo separate reference fixtures to perform CT and robot registration. InFIG. 29C, the CT reference fixture (N-shaped localizer) of FIG. 29Aattaches to the head frame (e.g., of FIG. 28A) temporarily during the CTscan. In FIG. 29D, the robot reference fixture of FIG. 29B, with postsover which the robot's guide tube passes, attaches temporarily to thehead frame for robot registration using the same mount points as the CTreference fixture. In FIG. 29C, the CT reference fixture is attached tohead frame and patient, and in FIG. 29D, the robot reference fixtureattached to head frame and patient.

As noted above, for robot registration relative to the head frame, therobot arm may be guided down over posts, holes, balls or sockets on areference fixture (e.g., of FIG. 28B/D or FIG. 29B/D) that issimultaneously rigidly attached to the patient and robot to establishreference positions. That is, some non-limiting options for matingfeatures on the robot and the robot reference fixture could be: (1)posts on the reference fixture (e.g., as shown in FIGS. 28B/D or 29B/D),over which a tube held by the end effector slides until bottoming out;(2) holes on the reference fixture, into which a post held by therobot's end effector slides until bottoming out; (3) spheres protrudingfrom the reference fixture, over which a socket-shaped assembly held bythe robot fits; or (4) sockets on the reference fixture, into which asphere-ended piece held by the robot fits. Any other suitable matingfeatures could also be effective. Posts or holes may be preferred overballs or sockets because posts/holes may require matching of a line inspace and not just a single point, and so it may be more likely thatbetter accuracy will be achieved in the detected position of thefeatures. FIGS. 30A and 30B show the robot being positioned over two ofthe three posts. For registration, at least two non-parallel posts(lines) may need to be identified or at least 3 points (balls/sockets)may need to be identified. It may also be advantageous to drive therobot all the way down over the post until it bottoms out at a knownlocation along the line, although not necessary to find a solutionunless posts are parallel.

The robot can be manually driven over the posts/holes or balls/socketsthrough joystick control, force control (utilizing a bracelet on the endeffector that responds to user-applied forces), or automatic control.Automatic control could include, for example, a force feedback mechanismthat guides movement of the robot arm as its guide tube slides over apost on the reference fixture, keeping the post centered within theguide tube. Or automatic control could include optical trackingfeedback, where the tracking system detects the posts on the referencefixture and moves the end effector's guide tube down over the posts. Or,automatic control could include a combination of optical and forcefeedback.

FIGS. 30A and 30B show the robot end effector being manually orautomatically guided over localizing features on the reference fixture.In FIG. 30A, the guide tube of the end effector is shown partially overthe left rear post, and in FIG. 30B, the guide tube of the end effectoris shown fully over (bottomed out on) right front post.

An additional implementation for the step of finding the location of theframe using the robot could be to attach a calibrated camera to the endeffector and perform mono-tracking (as opposed to stereo tracking) invisible or infrared IR light. A patterned object may be placed on thehead frame in a known position and orientation and the robot could bemanually or automatically positioned to register the robot to the headframe. For use with mono-tracking, a pattern that requires viewing froma particular unambiguous vector may be preferred. For example, a“bullseye” with two same- or different-sized rings at differentdistances where the rings are only concentric at a particular locationof the end-effector could be used. Or, a ring pattern applied to asphere or cone, where the rings are only concentric and circular if thesphere or cone is viewed from a particular orientation could be used. Ora dark pattern could be applied only to a sub-portion of a sphere, suchthat the camera only views the pattern symmetrically if the end-effectoris viewing it from a particular perspective. An example is discussedbelow with respect to FIG. 31.

FIG. 31 shows the robot end effector holding a camera that provides aview aligned with the centerline of the tube. The robot is automaticallyor manually positioned until it is viewing each target from aperspective that renders the target's pattern symmetrical, allowingregistration when three or more aligned perspectives are viewed sinceonly one robotic coordinate system can achieve simultaneous alignment ofthe three perspectives. In this example, the pattern on a hemisphereappears as an ‘X’, but only when viewed from a straight-on perspective.From other off-axis perspectives, the camera detects the pattern asasymmetrical, with the legs of the X being different lengths and the Xoff-center.

This method could also be used with conventional binocular opticaltracking (e.g., Polaris Spectra, Northern Digital, Inc.) during initialsetup. Optical markers could be placed on the head frame, such as theDynamic Reference Base (DRB), and in or around the guide tube of the endeffector, such as the active marker array (AMA) or the Passive TubeArray (PTA). If the DRB location relative to the frame is known and theAMA/PTA location relative to the end effector is known, registration iscomplete as soon as the cameras capture a frame of tracking informationwith both DRB and AMA/PTA in view. Since the transformation between DRBand AMA/PTA may be known once tracking data are captured and the robotis rigidly locked to the patient and cannot move, the DRB and AMA/PTAare no longer needed and can be removed or deactivated. With the DRB andAMA/PTA removed/deactivated, robotic inverse and forward kinematics asdescribed earlier would then be used for further positioning during theprocedure. If patient re-positioning is needed, the robot could beeasily re-registered to the new patient position by re-attaching the DRBand re-attaching the PTA or reactivating the AMA and capturing newtracking data.

According to some embodiments of inventive concepts, a robot may be usedwithout requiring optical tracking during the procedure, toreduce/eliminate line-of-sight issues that may be common with currentoptically tracked robotic systems.

Turning to FIGS. 32A-39B, exemplary embodiments of a detachable drillguide for cranial electrode placement are disclosed. Presently, a methodfor cranial electrode placement may include a patient tracker or dynamicreference base (DRB) and a method for registering medical images totracking space. Although it is possible to register and track using aDRB developed for other applications, such as robot assisted spinesurgery, and an additional tracked fixture such as an intraoperative CTregistration fixture (ICT), the mostly spherical shape of the skull mayallow customized registration and tracking fixtures. In the spine, aspinous process clamp or a spike into the ilium is used to mount theDRB. However, in the skull, such a method may be unworkable orinfeasible. One way to attach a DRB to the skull such that it cannotrotate or become dislodged is to use multiple screws. However,accordingly to exemplary embodiments of the present disclosure, to keepthe number of holes created in a patient's skull to a minimum, a DRB3200 having a single screw is illustrated in FIGS. 32A-32B. DRB 3200also has spikes 3202 to add additional frictional stability on the scalpor exposed skull bone without the morbidity of additional holes into thebone.

FIGS. 32A-B show top and bottom views of a cranial DRB 3200. A singlescrew through an opening 3204 secures DRB 3200 to the skull. Threespikes 3202 on the underside of the DRB provide additionalstabilization. DRB 3200 may also include notches 3208 for aligning aregistration skirt as described below.

To register, a skirt fixture 3300 of known dimensions with radio-opaquemetal spheres 3302 embedded in the skirt frame at known locationsrelative to optical spheres 3210 of DRB 3200 is temporarily attached(FIG. 33A-B). Fixture 3300 is in place during a CT scan and is thenremoved after the scan is obtained.

FIGS. 33A-B show DRB 3200 with and without fixture 3300 attached, whichis present only during the scan. The fixture locks into the base of DRB3200 in one orientation, dictated by the asymmetrical notches 3208visible at the base of DRB 3200. Fixture 3300 may be embedded withmultiple bearing balls (BBs), for example seven (7) BBs may be embeddedin an asymmetrical pattern that is detected automatically from the CTscan volume using image processing. One or more tracking cameras maytrack a position of optical tracking spheres 3210 on DRB 3200 and sincethe positions of tracking spheres 3210 relative to the BBs are fixed andknown, registration of tracking to anatomy may be achieved.

Before usage of an electrode placement tool, DRB 3200 would first beattached to the patient's skull in a position away from the electrodesite and registered by collecting a CT scan or another type of scan,such as an O-Arm (cone beam CT) scan.

An exemplary electrode guide 3400 consistent with the principles of thepresent disclosure is illustrated in FIGS. 34A-C. FIGS. 34A-C illustrateguide tube 3402 and accessories. FIG. 34A illustrates guide tube 3402with a detachable electrode holder 3404 at a distal tip of guide tube3402. Electrode holder 3404 may be threaded into the skull, which mayhave been drilled and tapped to receive the threaded portion ofelectrode holder 3404. Guide tube 3402 may include flat portions 3406near the top of guide tube 3402 to assist in inserting guide tube 3402with a wrench.

In FIG. 34B, once guide tube 3402 is in place in the skull, a tripodmechanism 3408 comes down over guide tube 3402 to allow adjustment of anangle of guide tube 3402 relative to the skull. Tripod mechanism 3408 istemporarily locked with a set screw to guide tube 3408 to prevent tripodmechanism 3408 from sliding up and down guide tube 3402. Feet 3410 ofthe tripod mechanism 3408 press against the skull but are not attachedto the skull and their positions may adjustable using knobs 3412.

In FIG. 34C, the current tube angle relative to anatomy is monitoredusing a tracked array 3414 that is attached to the top of guide tube3402. Array 3414 may freely rotate about an axis of guide tube 3402since the system needs only to track the vector (line) down the centerof guide tube 3402, which will be the path of the electrode.

A method or workflow using the system described herein may include thefollowing steps. DRB 3200 may be attached to the skull of a patient andtemporary skirt fixture 3300 may be attached to DRB 3200. A CT scan orO-Arm spin may be obtained to receive images of the target anatomy andsystem software may auto-detect BBs and auto-register tracking to theimage.

After the scan, fixture 330 may be removed from DRB 3200.

A trajectory may be planned of the electrode on the obtained medicalimages. These medical images may comprise the CT scan just obtained ormerged MM and CT scans. An end-effector 3500 of a robot mayautomatically move into place above the scalp of the patient. A laserheld by end-effector 3500 may point to an entry location on the skin toassist in cutting a flap as shown in FIG. 35.

The skull may be exposed and a user may drill a craniotomy pilot holewhile the robot guides the drill. The hole in the skull may be tapped toprovide threads to lock to electrode holder 3404. As shown in FIG. 36,the robot may guide tap 3600.

Electrode holder 3404 may be screwed into the threaded hole, with therobot providing guidance for the location. The robot may then beremoved, leaving electrode holder 3404 and guide tube 3402 as shown inFIG. 37.

Tripod mechanism 3408 is lowered into place over guide tube 3402. Feet3410 may be adjusted so that tripod mechanism 3408 does not alter theorientation of guide tube 3402 while all three feet simultaneously touchthe scalp. Additionally, the position of the tripod feet 3410 in theirrotation about the guide tube 3402 may be adjusted so that they avoidcontact with the DRB or other adjacent surgical equipment such asretractors. Once in place, tripod mechanism 3408 may be locked to guidetube 3402 with a set screw as shown in FIG. 38.

Tracking array 3414 may then be attached to the top of guide tube 3402as shown in FIG. 39B. Alignment of guide tube 3402 is checked relativeto the plan using navigation. Feet 3410 may be adjusted as necessary tomatch the plan. A software feature may show a top-down view 3900 toassist in fine-tuning the trajectory as shown in FIG. 39A. Additionally,the system may provide software feedback on which of feet 3410 to adjustand in which direction by how many turns to adjust each. To do so,software may know the orientation of feet 3410 relative to DRB 3200,which can be determined by placing fiducials on each foot of the tripod,through natural fiducial recognition, or by the user specifying in asoftware interface how the feet are oriented.

An electrode is then inserted into guide tube 3402 through electrodeholder 3404 to the desired depth within the brain. The guide tube 3402is disengaged from electrode holder 3404 and removed, leaving behindelectrode holder 3404. This method or workflow may be repeated foradditional electrodes.

In the above-description of various embodiments of present inventiveconcepts, it is to be understood that the terminology used herein is forthe purpose of describing particular embodiments only and is notintended to be limiting of present inventive concepts. Unless otherwisedefined, all terms (including technical and scientific terms) usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which present inventive concepts belong. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of this specification andthe relevant art and will not be interpreted in an idealized or overlyformal sense unless expressly so defined herein.

When an element is referred to as being “connected”, “coupled”,“responsive”, or variants thereof to another element, it can be directlyconnected, coupled, or responsive to the other element or interveningelements may be present. In contrast, when an element is referred to asbeing “directly connected”, “directly coupled”, “directly responsive”,or variants thereof to another element, there are no interveningelements present. Like numbers refer to like elements throughout.Furthermore, “coupled”, “connected”, “responsive”, or variants thereofas used herein may include wirelessly coupled, connected, or responsive.As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. Well-known functions or constructions may not be described indetail for brevity and/or clarity. The term “and/or” includes any andall combinations of one or more of the associated listed items.

It will be understood that although the terms first, second, third, etc.may be used herein to describe various elements/operations, theseelements/operations should not be limited by these terms. These termsare only used to distinguish one element/operation from anotherelement/operation. Thus a first element/operation in some embodimentscould be termed a second element/operation in other embodiments withoutdeparting from the teachings of present inventive concepts. The samereference numerals or the same reference designators denote the same orsimilar elements throughout the specification.

As used herein, the terms “comprise”, “comprising”, “comprises”,“include”, “including”, “includes”, “have”, “has”, “having”, or variantsthereof are open-ended, and include one or more stated features,integers, elements, steps, components or functions but does not precludethe presence or addition of one or more other features, integers,elements, steps, components, functions or groups thereof. Furthermore,as used herein, the common abbreviation “e.g.”, which derives from theLatin phrase “exempli gratia,” may be used to introduce or specify ageneral example or examples of a previously mentioned item, and is notintended to be limiting of such item. The common abbreviation “i.e.”,which derives from the Latin phrase “id est,” may be used to specify aparticular item from a more general recitation.

Example embodiments are described herein with reference to blockdiagrams and/or flowchart illustrations of computer-implemented methods,apparatus (systems and/or devices) and/or computer program products. Itis understood that a block of the block diagrams and/or flowchartillustrations, and combinations of blocks in the block diagrams and/orflowchart illustrations, can be implemented by computer programinstructions that are performed by one or more computer circuits. Thesecomputer program instructions may be provided to a processor circuit ofa general purpose computer circuit, special purpose computer circuit,and/or other programmable data processing circuit to produce a machine,such that the instructions, which execute via the processor of thecomputer and/or other programmable data processing apparatus, transformand control transistors, values stored in memory locations, and otherhardware components within such circuitry to implement thefunctions/acts specified in the block diagrams and/or flowchart block orblocks, and thereby create means (functionality) and/or structure forimplementing the functions/acts specified in the block diagrams and/orflowchart block(s).

These computer program instructions may also be stored in a tangiblecomputer-readable medium that can direct a computer or otherprogrammable data processing apparatus to function in a particularmanner, such that the instructions stored in the computer-readablemedium produce an article of manufacture including instructions whichimplement the functions/acts specified in the block diagrams and/orflowchart block or blocks. Accordingly, embodiments of present inventiveconcepts may be embodied in hardware and/or in software (includingfirmware, resident software, micro-code, etc.) that runs on a processorsuch as a digital signal processor, which may collectively be referredto as “circuitry,” “a module” or variants thereof.

It should also be noted that in some alternate implementations, thefunctions/acts noted in the blocks may occur out of the order noted inthe flowcharts. For example, two blocks shown in succession may in factbe executed substantially concurrently or the blocks may sometimes beexecuted in the reverse order, depending upon the functionality/actsinvolved. Moreover, the functionality of a given block of the flowchartsand/or block diagrams may be separated into multiple blocks and/or thefunctionality of two or more blocks of the flowcharts and/or blockdiagrams may be at least partially integrated. Finally, other blocks maybe added/inserted between the blocks that are illustrated, and/orblocks/operations may be omitted without departing from the scope ofinventive concepts. Moreover, although some of the diagrams includearrows on communication paths to show a primary direction ofcommunication, it is to be understood that communication may occur inthe opposite direction to the depicted arrows.

Although several embodiments of inventive concepts have been disclosedin the foregoing specification, it is understood that many modificationsand other embodiments of inventive concepts will come to mind to whichinventive concepts pertain, having the benefit of teachings presented inthe foregoing description and associated drawings. It is thus understoodthat inventive concepts are not limited to the specific embodimentsdisclosed hereinabove, and that many modifications and other embodimentsare intended to be included within the scope of the appended claims. Itis further envisioned that features from one embodiment may be combinedor used with the features from a different embodiment(s) describedherein. Moreover, although specific terms are employed herein, as wellas in the claims which follow, they are used only in a generic anddescriptive sense, and not for the purposes of limiting the describedinventive concepts, nor the claims which follow. The entire disclosureof each patent and patent publication cited herein is incorporated byreference herein in its entirety, as if each such patent or publicationwere individually incorporated by reference herein. Various featuresand/or potential advantages of inventive concepts are set forth in thefollowing claims.

What is claimed is:
 1. A surgical robot system for attaching anelectrode holder to a skull of a patient, the electrode holderconfigured to receive an electrode to be inserted into a brain of thepatient, said surgical robot system comprising: a robot base comprisinga computer; a robot arm coupled to the robot base; an end effectorconfigured to be coupled to the robot arm; a guide tube having adetachable electrode holder disposed at a distal tip of the guide tipand a tracking array disposed near a proximal end of the guide tube, theguide tube configured to couple to the end effector; a tripod mechanismconfigured to slide over the guide tube and allow adjustment of an angleof the guide tube relative to the skull.
 2. The surgical robot system ofclaim 1, wherein guide tube is configured to receive an electrode. 3.The surgical robot system of claim 2, wherein the detachable electrodeholder comprises threads that are configured to be received by theskull.
 4. The surgical robot system of claim 3, wherein the guide tubeis configured to be removed from the electrode holder after theelectrode has been introduced into the skull.
 5. The surgical robotsystem of claim 4, wherein the tracking array is configured to allowtracking of an angle of the guide tubed via a camera.
 6. The surgicalrobot system of claim 5, wherein the tripod mechanism comprises one ormore feet that may be configured to rest on the skull withoutpenetrating the skull.
 7. The surgical robot system of claim 6, whereineach of the feet are configured to be adjusted via a knob.
 8. Thesurgical robot system of claim 7, wherein the one or more feet areconfigured to angularly adjust the guide tube.
 9. The surgical robotsystem of claim 8, wherein the tripod mechanism is configured to betemporarily locked to the guide tube with a set screw.
 10. The surgicalrobot system of claim 9, wherein the robot base is configured toposition the end-effector adjacent to the skull at a trajectoryconsistent with a desired trajectory for insertion of the electrode. 11.A method of using a surgical robot for attaching an electrode holder toa skull of a patient, the electrode holder configured to receive anelectrode to be inserted into a brain of the patient, said methodcomprising: planning a trajectory, using the surgical robot, forinsertion of the electrode into the brain, wherein the surgical robotcomprises: a robot base comprising a computer; a robot arm coupled tothe robot base; an end effector configured to be coupled to the robotarm; a guide tube having a detachable electrode holder disposed at adistal tip of the guide tip and a tracking array disposed near aproximal end of the guide tube, the guide tube configured to couple tothe end effector; a tripod mechanism configured to slide over the guidetube and allow adjustment of an angle of the guide tube relative to theskull; positioning a dynamic reference base on the skull; positioning atemporary skirt fixture to the dynamic reference base; obtaining medicalimages of the dynamic reference base and temporary skirt feature;registering the dynamic reference base to the medical images using thetemporary skirt fixture; removing the temporary skirt fixture; planninga trajectory of the electrode using the obtained medical images; usingthe robot to move the robot arm and end-effector to a desired locationadjacent to the skull along the planned trajectory; using a drill toprovide a hole in the skull while the robot guides the drill; providingthe guide tube and electrode holder in the hole and removing the robot;lowering and locking the tripod mechanism to the guide tube; providingthe tracking array to the guide tube and checking alignment of the guiderelative to the planned trajectory; inserting an electrode into theguide tube and through the electrode holder; and removing the guide tubefrom the electrode holder.
 12. The method of claim 11, wherein guidetube is configured to receive an electrode.
 13. The method of claim 12,wherein the detachable electrode holder comprises threads that areconfigured to be received by the skull.
 14. The method of claim 13,wherein the guide tube is configured to be removed from the electrodeholder after the electrode has been introduced into the skull.
 15. Themethod of claim 14, wherein the tracking array is configured to allowtracking of an angle of the guide tubed via a camera.
 16. The method ofclaim 15, wherein the tripod mechanism comprises one or more feet thatmay be configured to rest on the skull without penetrating the skull.17. The method of claim 16, wherein each of the feet are configured tobe adjusted via a knob.
 18. The method of claim 17, wherein the one ormore feet are configured to angularly adjust the guide tube.
 19. Themethod of claim 18, wherein the tripod mechanism is configured to betemporarily locked to the guide tube with a set screw.
 20. The method ofclaim 19, wherein the robot base is configured to position theend-effector adjacent to the skull at a trajectory consistent with adesired trajectory for insertion of the electrode.